- )
-}
-
-ChartBar.displayName = 'component/ChartBar'
-export default ChartBar
diff --git a/components/ChartDonut.jsx b/components/ChartDonut.jsx
deleted file mode 100644
index ebd82dfb..00000000
--- a/components/ChartDonut.jsx
+++ /dev/null
@@ -1,147 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import cx from 'classnames'
-import Charts from 'react-chartjs'
-import getFieldValues from '../utils/getFieldValues'
-
-const Doughnut: ReactClass = Charts.Doughnut
-
-const _getChartColor = function (i: number): string {
- const colors: Array = [
- '#025181',
- '#4874bd',
- '#9bdaf1',
- '#2e8540',
- '#a1c974',
- '#b7e062',
- '#571873',
- '#9a47aa',
- '#ca9af1',
- ]
-
- return colors[i]
-}
-
-const _getChartData = function (
- data: Array,
- fieldValues: Object,
- colors: Array,
- hasLegend: boolean) {
-
- // $FlowIgnore because of the filter
- return data.map((d: Object, i) => {
- const color: string = !colors ? _getChartColor(i) : colors[i]
- const label: void|string = fieldValues[d.term] || d.term
-
- // hasLegend === main donut chart, not sidebar record chart
- // the sidebar record chart won't have labels, so we
- // check for those things so the chart doesn't err
- // we also want to limit the things we are rendering
- // to be things that are actually in fieldValues
- if (hasLegend && typeof label === 'undefined') return
-
- return {
- value: d.count,
- color,
- label,
- }
- }).filter(d => d)
-}
-
-type tPROPS = {
- colors: Array;
- countParam: string;
- data: Array;
- fields: Object;
- hasLegend: boolean;
- records: number;
- size: string;
-};
-
-/**
- * @description [reactjs chart for endpoint basics pages]
- * [slightly different logic depending on placement]
- * @param {Array} colors [array of acceptable colors we cycle through]
- * @param {string} countParam [filter by value]
- * @param {Object} fields [all data for this endpoint]
- * @param {boolean} hasLegend [big donut charts get legends, small ones don't]
- * @param {number} size [number of pxs to render. small vs big]
- */
-const ChartDonut = (props: tPROPS) => {
- const {
- colors,
- countParam,
- data,
- fields,
- hasLegend,
- size,
- } = props
-
- const fieldValues: Object = getFieldValues(countParam, fields)
- // map over data, return as arr of obj formatted for chart js
- const chartData: Array = _getChartData(data, fieldValues, colors, hasLegend)
- // always map over all data, sometimes chartData can be a subset
- const total: number = data.map(d => d.count).reduce((a, b) => a + b)
-
- const legendCx = cx({
- 'col t-range-6 d-3 marg-t-2 d-marg-l-2': true,
- 'd-pad-l-2 overflow-scroll donut-legend': true,
- })
-
- const wrapperCx = cx({
- 'flex-row align-center donut-wrap': true,
- 'm-hide': !hasLegend,
- })
-
- return (
-
-
- {
- hasLegend &&
-
- {
- chartData.map((d: Object, i) => {
- // get % of records that the current field matches
- const porCiento: number = (d.value / total) * 100 | 0
-
- return (
-
-
-
- {d.label}
- {porCiento}% - {d.value} records
-
-
- )
- })
- }
-
- }
-
- )
-}
-
-ChartDonut.displayName = 'component/ChartDonut'
-export default ChartDonut
diff --git a/components/ChartLine.jsx b/components/ChartLine.jsx
deleted file mode 100644
index d2481f8d..00000000
--- a/components/ChartLine.jsx
+++ /dev/null
@@ -1,203 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import Charts from 'react-chartjs'
-import get from 'lodash/get'
-import ChartBar from './ChartBar'
-
-const Line: ReactClass = Charts.Line
-
-/**
- * @description [loops over the data, pulls out each year]
- * @param {Object} data [result of the api call]
- * @return {Array} [returns array of years]
- */
-const _getYearsInData = (data: Array) => {
- if (!data[0] || !data[0].time) return
-
- // get first matching year
- // string: 2004 08 19 -> string: 2004
- let year: string = data[0].time.slice(0, 4)
- // we'll keep a record of the years so far
- // and we'll start with the first one above
- const years: Array = [year]
-
- data.forEach(d => {
- // is the year for this bit of data
- // already accounted for?
- const oldYear: boolean = d.time.indexOf(year) !== -1
-
- // if yes, do nothing
- // if no, then pull out
- // the year and push that up
- if (!oldYear) {
- const newYear: string = d.time.slice(0, 4)
-
- year = newYear
- return years.push(newYear)
- }
- })
-
- // return final arr of all
- // mentioned years
- return years
-}
-
-/**
- * @description [takes in data and years, then groups said data by year]
- * @param {Array} data [result of the api call]
- * @param {Array} years [result of _getYearsInData]
- * @return {Object} [returns an Object where each key is a year, whose values are an array of records]
- */
-const _getRecordsByYear = (data: Array, years: Array) => {
- const dataByYear: Object = {}
-
- years.forEach(y => {
- dataByYear[y] = []
- })
-
- data.forEach(d => {
- const year: string = d.time.slice(0, 4)
- return dataByYear[year].push(d)
- })
-
- return dataByYear
-}
-
-/**
- * @description [reduces records, grouped by year]
- * @param {Object} data [takes in result of _getRecordsByYear]
- * @return {Array} [returns simple array of reduced records]
- */
-const _getTotalsByYear = (data: Object) => {
- return Object.keys(data).map(y => {
- return data[y]
- .map(d => d.count)
- .reduce((a, b) => a + b)
- })
-}
-
-const _getChartData = (years: Array, totalsByYear: Array) => {
- return {
- labels: years,
- datasets: [{
- data: totalsByYear,
- fillColor: 'rgba(17, 46, 81, .3)',
- strokeColor: '#112e51',
- pointColor: '#112e51',
- pointStrokeColor: '#112e51',
- pointHighlightFill: '#fff',
- pointHighlightStroke: '#112e51',
- }],
- }
-}
-
-type PROPS = {
- countParam: string;
- data: Array;
- height: string;
- fields: Array;
- width: string;
-};
-
-let previousChartData: Object = {}
-
-
-/**
- * @description [reactjs chart for endpoint basics pages]
- * @param {string} countParam [filter by value]
- * @param {Array} data [an array of data cooresponding to DATES or YEARS]
- * @param {Object} height [height in px to render]
- * @param {boolean} fields [all data for endpoint]
- * @param {number} width [width in px to render]
- */
-const ChartLine = ({ countParam, data, height, fields, width, }: PROPS) => {
- const years: Array = _getYearsInData(data)
- let recordsByYear: Object = {}
- let totalsByYear: Array = [0]
-
- // not every line chart is necessarily date based
- if (years) {
- recordsByYear = _getRecordsByYear(data, years)
- totalsByYear = _getTotalsByYear(recordsByYear)
- }
-
- // we keep track so we don't redraw unnecessarily
- // chartjs normally takes care of this on it's own
- // but because we toggle animations on / off to prevent
- // sluggishness / bugginess with big datasets
- // we have to check ourselves and then force redraw
- // sometimes this results in non-responsiveness
- // but it is better than the alternative -
- // sluggishness that persists until the user refreshes
- const currChartData: Object = previousChartData
- const nextChartData: Object = _getChartData(years, totalsByYear)
- previousChartData = nextChartData
-
- let dataChanged: boolean = false
- const cData: Array = get(currChartData, 'datasets[0].data')
- const nData: Array = get(nextChartData, 'datasets[0].data')
-
- if (cData && nData) {
- // if we have both current and next chart data
- // we iterate over the dataset, and if -anything-
- // is not the same, we update
- dataChanged = cData.some((d, i) => nData[i] !== d)
- }
-
- // if something wrong happened with the years
- // try and fall back to a bar chart
- if (!years) {
- return (
-
- )
- }
-
- return (
-
-
-
- Skip Line Chart. Go to visualization query explorer.
-
-
-
- )
-}
-
-ChartLine.displayName = 'components/ChartLine'
-export default ChartLine
diff --git a/components/Content.jsx b/components/Content.jsx
deleted file mode 100644
index acde601f..00000000
--- a/components/Content.jsx
+++ /dev/null
@@ -1,156 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import marked from 'marked'
-import cx from 'classnames'
-
-import Datasets from './Datasets'
-import Downloads from './Downloads'
-import MultipleProductTable from './MultipleProductTable'
-import RenderContentObject from './RenderContentObject'
-
-type tPROPS = {
- content: Array;
- examples: Array;
- explorers: Object;
- fields: Object;
- showMenu: boolean;
- meta: Object;
-};
-
-
-
-// reads in _content.yaml from ideally anywhere
-// and knows what component to render for each field
-const Content = (props: tPROPS) => {
- const {
- content,
- examples,
- explorers,
- fields,
- showMenu,
- meta,
- } = props
-
- return (
-
- {
- content.map((words: string|Object, i) => {
- // lies, IT IS NOT WORDS
- // basically, stuff like disclaimer
- // or examples, or fields we want to render
- // or query explorers, basicaaaaaly
- // anything in _content that is not
- // a simple string gets passed to this
- if (typeof words === 'object') {
- return (
-
- )
- }
-
- // stringified markdown -> html
- const html: string = marked(words)
-
- // if header, add header class, etc
- const wrapperCx: string = cx({
- 'font-size-2 weight-700 marg-b-2 marg-t-3': html.indexOf('') !== -1,
- })
-
- // kind of a weird way to do this
- // but, it might be easier for non-technical
- // people to understand that they just type
- // 'downloads' to render that section
- if (words === 'downloads') {
- return (
-
- )
- }
-
- // as far as i can tell we just
- // have the one 'image' for drug/event
- if (words === 'datasets') {
- return (
-
- )
- }
-
- // as far as i can tell we just
- // have the one 'image' for drug/event
- if (words === 'image') {
- return (
-
- )
- }
-
- // below is where we handle just plain normal text
- // but we need to handle some edge cases first
- // specifically, all external links need the external link icon
- // so we
- // 1) check for http://
- // 2) use regex to grab all tags that match
- // 3) loop over matches, incrementally wrapping external links
- // with our wrapper class (link-external)
- // 4) finally output the linkified (or not) text
- //
- // assume that local links just do /path/path
- // instead of http://whatever
- const hasLink: boolean = html.indexOf('http://') !== -1
- // regex for matching tags WITH a valid http:// href
- const httpRE: RegExp = /]*?href[\s]?=[\s\"\']*(http:\/\/.*?)[\"\']*.*?>([^<]+|.*?)?<\/a>/gm
- // if no external links, just output the markdownified text
- // otherwise, we'll need to string replace the external links
- // with a wrapper element, for the external link icon
- let finalOutput: string = html
-
- if (hasLink) {
- // array of matches, we should have at least one
- const matches: ?Array = html.match(httpRE)
-
- // but just to be safe
- if (matches) {
- for (const match of matches) {
- const intermediate: string = finalOutput.replace(match, `${match}`)
- finalOutput = intermediate
- }
- }
- }
-
- return (
-
- )
- })
- }
-
- )
-}
-
-Content.displayName = 'component/Content'
-export default Content
diff --git a/components/ContentWrapper.jsx b/components/ContentWrapper.jsx
deleted file mode 100644
index d94c3e13..00000000
--- a/components/ContentWrapper.jsx
+++ /dev/null
@@ -1,97 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import cx from 'classnames'
-
-import EndpointStatus from './EndpointStatus'
-import SideBar from './SideBar'
-import Content from './Content'
-import Hero from './Hero'
-import Layout from './Layout'
-
-import SideBarContainer from '../containers/SideBarContainer'
-import InfographicContainer from '../containers/InfographicContainer'
-
-import mapFields from '../utils/mapFields'
-import flattenFields from '../utils/flattenFields'
-
-type tPROPS = {
- content: Array;
- explorers: Object;
- infographics: Array;
- fields: Object;
- showMenu: boolean;
- meta: Object;
-};
-
-const wrapperCx = cx({
- 'container t-marg-t-3 marg-b-3 relative row content-wrapper': true,
-})
-
-// add fixed positioning functinality to reference sidebar
-const ComposedSidebar: ReactClass = SideBarContainer(SideBar)
-
-// i just exist to render the Sidebar, and
-// determine whether we render ref specific
-// components or not
-const ContentWrapper = (props: tPROPS) => {
- const {
- content,
- explorers,
- infographics,
- fields,
- showMenu,
- meta
- } = props
-
- let fieldsMapped: Object = {}
- let fieldsFlattened: Object = {}
- if (explorers && fields) {
- fieldsMapped = mapFields(fields.properties)
- fieldsFlattened = flattenFields(fieldsMapped)
- }
-
- const contentCx = cx({
- 'float-r': true,
- 'ref-content': true,
- })
-
- return (
-
-
- {
-
- }
-
- {
-
- }
-
-
-)
-
-Dataset.displayName = 'components/Dataset'
-export default Dataset
diff --git a/components/Datasets.jsx b/components/Datasets.jsx
deleted file mode 100644
index 05efefdc..00000000
--- a/components/Datasets.jsx
+++ /dev/null
@@ -1,31 +0,0 @@
-/* @flow */
-
-import React from 'react'
-
-type tPROPS = {
- k: number;
- meta: Object;
-};
-
-// used by Content to render out datasets
-// used by the current endpoint
-const Datasets = (props: tPROPS) => (
-
-
Datasets
-
The following datasets provide data for this endpoint.
- {
- props.meta.datasets.map((dataset: string, i) => (
-
- {dataset}
-
- ))
- }
-
-)
-
-Datasets.displayName = 'components/Datasets'
-export default Datasets
diff --git a/components/Disclaimer.jsx b/components/Disclaimer.jsx
deleted file mode 100644
index 268c1452..00000000
--- a/components/Disclaimer.jsx
+++ /dev/null
@@ -1,54 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import ReactModal from 'react-modal'
-
-import ComposedDisclaimer from '../containers/DisclaimerContainer'
-
-const Link: ReactClass = require('react-router').Link
-
-type tPROPS = {
- showModal: boolean,
- handleOpenModal: Function,
- handleCloseModal: Function,
- hideModal: Function
-};
-
-/**
- * @description [renders meta data (yaml usually) as the hero el below breadcrumbs]
- * @param {string|React.Element} description [paragraph below title]
- * @param {string} label [small text right above the title]
- * @param {string} path [the page route, for endpoint pages]
- * @param {string} title [the title, used on non-endpoint pages (posts, etc)]
- * @param {string} type [endpoint or not, used for styling and tabs]
- * @return {React.Element}
- */
-const Disclaimer = (props: tPROPS) => {
- const {
- showModal,
- handleOpenModal,
- handleCloseModal,
- hideModal
- } = props
- console.log("dumb disclaimer showModal: ", showModal)
-
-
- return (
-
-
Disclaimer
-
- Do not rely on openFDA to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of FDA-regulated products. We may limit or otherwise restrict your access to the API in line with our Terms of Service
-
This endpoint’s data may be downloaded in zipped JSON files. Records are represented in the same format as API calls to this endpoint. Each update to the data in this endpoint could change old records. You need to download all the files to ensure you have a complete and up-to-date dataset, not just the newest files. For more information about openFDA downloads, see the API basics.
-
-
There are {allPartitions.length} files, last updated on {updated}.
- Header Information
- Report ID, receive date, etc.
-
-
- Patient information
- Age, weight, sex, etc.
-
-
-
- Drugs
-
-
Drug A suspect
-
Drug B suspect
-
Drug C suspect
-
Drug D concomitant
-
Drug E concomitant
-
-
-
- Patient reactions
-
-
Reaction 1
-
Reaction 2
-
Reaction 3
-
-
-
-
-)
-
-DrugQueryTable.displayName = 'components/DrugQueryTable'
-export default DrugQueryTable
diff --git a/components/EndpointBox.jsx b/components/EndpointBox.jsx
deleted file mode 100644
index 990021b2..00000000
--- a/components/EndpointBox.jsx
+++ /dev/null
@@ -1,137 +0,0 @@
-/* @flow */
-
-import React from 'react'
-
-const Link: ReactClass = require('react-router').Link
-
-type tPROPS = {
- noun_name: string,
- endpoint_name: string
-};
-
-/**
- * @description [renders meta data (yaml usually) as the hero el below breadcrumbs]
- * @param {string|React.Element} description [paragraph below title]
- * @param {string} label [small text right above the title]
- * @param {string} path [the page route, for endpoint pages]
- * @param {string} title [the title, used on non-endpoint pages (posts, etc)]
- * @param {string} type [endpoint or not, used for styling and tabs]
- * @return {React.Element}
- */
-const EndpointBox = (props: tPROPS) => {
- const {
- noun_name,
- endpoint_name
- } = props
-
- const description = {
- 'food': {
- 'enforcement': 'Food product recall enforcement reports.',
- 'event': 'Food, dietary supplement, and cosmetic adverse event reports.'
- },
- 'device': {
- 'event': 'Reports of serious injuries, deaths, malfunctions, and other undesirable effects associated with the use of medical devices.',
- 'classification': 'Medical device names, their associated product codes, their medical specialty areas (panels) and their classification.',
- '510k': 'A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.',
- 'pma': 'Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.',
- 'registrationlisting': 'The registration and listing dataset contains the location of medical device establishments and the devices manufactured at those establishments.',
- 'recall': 'A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.',
- 'enforcement': 'Medical device product recall enforcement reports.',
- 'udi': 'Global Unique Device Identification Database (GUIDID) Device Identification dataset.'
- },
- 'drug': {
- 'event': 'Reports of drug side effects, product use errors, product quality problems, and therapeutic failures.',
- 'label': 'Structured product information, including prescribing information, for approved drug products.',
- 'enforcement': 'Drug product recall enforcement reports.'
- },
- }
-
- const ep_title = {
- 'food': {
- 'enforcement': 'Recall enforcement reports',
- 'event': 'CAERS reports'
- },
- 'device': {
- 'event': 'Adverse event reports',
- 'classification': 'Classification',
- '510k': '510(k) clearances',
- 'pma': 'Premarket approval',
- 'registrationlisting': 'Registrations and listings',
- 'recall': 'Recalls',
- 'enforcement': 'Recall enforcement reports',
- 'udi': 'Unique device identifier'
- },
- 'drug': {
- 'event': 'Adverse events',
- 'label': 'Product labeling',
- 'enforcement': 'Recall enforcement reports'
- },
- }
- const bg_color = {
- 'food': {background: "linear-gradient(to right bottom, rgb(143, 209, 100), rgb(81, 161, 22))"},
- 'device': {background: "linear-gradient(to right bottom, rgb(255, 198, 59), rgb(243, 117, 73))"},
- 'drug': {background: "linear-gradient(to right bottom, rgb(220, 141, 188), rgb(153, 88, 163))"}
- }
-
- const icon = {
- 'food': {
- 'enforcement':
- {
- data.error &&
-
- Request returned no response.
- Change your search and/or count parameters and try again
-
- }
- {
- !fieldDefinition &&
-
- No Field Definition found in fields yaml.
- Please fix the missing field and try again
-
- }
- {
- !error &&
-
- }
-
- )
-}
-
-QueryExplorer.displayName = 'components/QueryExplorer'
-export default QueryExplorerContainer(QueryExplorer)
diff --git a/components/RenderContentObject/Fields.jsx b/components/RenderContentObject/Fields.jsx
deleted file mode 100644
index 4e96c84c..00000000
--- a/components/RenderContentObject/Fields.jsx
+++ /dev/null
@@ -1,237 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import marked from 'marked'
-
-import get from 'lodash/get'
-import Values from './Values'
-import yamlGet from '../../utils/yamlGet'
-
-const labelCx: string = 'bg-primary-alt-lightest clr-gray inline-block sans weight-600 small marg-b-1'
-const labelStyl: Object = {
- borderRadius: '3px',
- padding: '2px 5px'
-}
-const typeCx: string = 'clr-gray sans small'
-const typeStyl: Object = {
- fontStyle: 'italic',
- marginLeft: '10px',
-}
-
-type tLiProps = {
- field: void|Object;
- key: string;
- i: number;
- isFDA: void|boolean;
-};
-
-/**
- * @description [renders an individual field]
- * [openfda fields are a little different]
- * @param {Object} props [the field to render, fieldname(key)]
- * [the key(i) and if this is an openfda field]
- * @return {React.Element} [always render an element]
- */
-const _renderLi = (props: tLiProps) => {
- const {
- field,
- key,
- i,
- isFDA,
- } = props
-
- // array
- let type: string = ''
- // one_of, etc
- let values: ?Object = null
- // of strings
- let type2: string = ''
- // description text, can have markdown
- let desc: string = ''
- // query syntax pattern
- let pattern: string = ''
- // whether field has .exact
- let isExact: bool = false
-
- if (field) {
- desc = field.description
- pattern = field.pattern
- type = field.type
- values = field.possible_values
- isExact = field.is_exact && field.is_exact
- }
-
- // field is an array (will have subkey of items)
- if (field && field.items) {
- desc = field.items.description
- pattern = field.items.pattern
- type2 = field.items.type
- }
-
- const divCx: string = 'col t-range-marg-t-2 t-range-6 d-3'
-
- return (
-
-
-
-
- {key.replace('.properties', '')}
-
- {type}{type2 && ` of ${type2}s`}
-
-
-
-
- {
- desc &&
-
- }
- {
- isExact &&
-
-
This is an .exact field. It has been indexed both as its exact string content, and also tokenized.
-
-
-
search={key}:"FOO+BAR"
- Searches for records where either FOO or BAR appear anywhere in this field.
-
-
-
search={key}.exact:"FOO+BAR"
- Searches for records where exactly and only FOO BAR appears in this field.
-
-
-
count={key}
- Counts the tokenized values of this field. Instances of FOO and BAR are counted separately.
-
-
-
count={key}.exact
- Counts the exact values of this field. FOO BAR, BAR FOO, FOO, and BAR would all be counted separately, along with other combinations that contain these terms.
- )
-}
-
-// @TODO we can probably do away
-// with this intermediate step
-const _renderFDA = (key: string, data) => {
- const fieldKeys: Array = data ? Object.keys(data) : ['']
-
- const fieldData: Array = fieldKeys.map((key: string, i) => {
- const field: void|Object = data && data[key]
-
- if (!field) return null
-
- return _renderLi({
- field,
- i,
- isFDA: true,
- key,
- })
- })
-
- return (
-
- {fieldData}
-
- )
-}
-
-type tPROPS = {
- // which fields to render
- data: Array;
- // fields obj
- fields: Object;
- k: number;
-};
-
-/**
- * @description [fields refers to the api field property documentation]
- * [that gets rendered out on reference pages]
- * @param {Array} data [the fields for the specific section we want to render]
- * @param {Object} [fields] [all fields possible for this endpoint]
- * @return {React.Element} [always return an element]
- */
-const Fields = ({ data, fields, k }: tPROPS) => {
- const fieldData: Array = data.map((key: string, i) => {
- const field = yamlGet(key, fields)
-
- if (!field) {
- console.log('could not find in _fields.yaml:', key)
- return
- }
-
- // openfda key is a special case
- if (key.indexOf('openfda') !== -1) {
- return _renderFDA(
- key,
- field
- )
- }
-
- return _renderLi({
- field,
- i,
- isFDA: false,
- key,
- })
- })
-
- return (
-
- {fieldData}
-
- )
-}
-
-Fields.displayName = 'component/Reference/Fields'
-export default Fields
diff --git a/components/RenderContentObject/Values.jsx b/components/RenderContentObject/Values.jsx
deleted file mode 100644
index b005de0c..00000000
--- a/components/RenderContentObject/Values.jsx
+++ /dev/null
@@ -1,80 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import cx from 'classnames'
-
-const labelCx: string = 'bg-primary-alt-lightest clr-gray inline-block sans weight-600 small marg-b-1'
-const labelStyl: Object = {
- borderRadius: '3px',
- padding: '2px 5px'
-}
-
-type PROPS = {
- values: Object;
-};
-
-// the possible values field is pretty much
-// always rendered the same so just generalize
-// we don't always render values, and sometimes there
-// can be a lot of them for a particular field
-// so we render differently depending on length here
-const Values = ({ values }: PROPS) => {
- const valueKeys: Array = Object.keys(values.value)
-
- const colCx = cx({
- 'col marg-b-1': true,
- 't-3': valueKeys.length >= 11,
- 't-6': valueKeys.length <= 10,
- })
-
- // possible_values is a list of specific values
- // e.g. drug administration routes or genders
- if (values.type === 'one_of') {
- return (
-
-
- Value is one of the following
-
-
- {
- valueKeys.map((v: string, i) => (
-
-
- {v} = {values.value[v]}
-
-
- ))
- }
-
-
- )
- }
-
- // possible_values references another dataset or external service
- // e.g. MedDRA for patient reactions
- if (values.type === 'reference') {
- return (
-
- )
- }
-
- // The possible_values were not correctly typed/described in _fields.yaml
- return
-}
-
-export default Values
diff --git a/components/RenderContentObject/index.jsx b/components/RenderContentObject/index.jsx
deleted file mode 100644
index 19b3fdbe..00000000
--- a/components/RenderContentObject/index.jsx
+++ /dev/null
@@ -1,239 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import cx from 'classnames'
-import marked from 'marked'
-import Highlight from 'react-highlight'
-
-import Fields from './Fields'
-import QueryExplorer from '../QueryExplorer'
-
-const linkCx: string = 'b-b-1 clr-primary-alt-dark block font-size-5 pad-1 pad-l-2 txt-l row'
-
-type tPROPS = {
- obj: Object;
- k: number;
- examples: Object;
- explorers: Object;
- fields: Object;
- isMenu: boolean;
- onClick: Function;
-};
-
-// called by Content
-// normally _content.yaml contains string content that
-// we either render out directly, or use as a flag
-// to know when to render other components
-//
-// sometimes though we have object in _content, usually
-// for api examples or for rendering out fields for an
-// endpoint. this component handles rendering the objects
-const RenderContentObject = (props: tPROPS) => {
- const {
- // obj passed in via Content from a _fields.yaml
- obj,
- // key basically. can't pass key as prop
- k,
- // big pre blocks (code examples) on some pages
- examples,
- // data for rendering an interactive query explorer
- explorers,
- // fields from content.yaml, for rendering a reference
- fields,
- // these 2 only used by ReferenceMenu
- // isMenu is used to parse content for the sidebarMenu
- // onClick just scrolls the page without messing up the url
- isMenu,
- onClick,
- } = props
-
- // there should only be one key
- // in the YAML, the objects are structured like
- // queryExplorer: 'keyOfWhichExplorerToUse'
- // or like
- // ul:
- // - list stuff
- const key: string = Object.keys(obj)[0]
- // normalize the key
- const lowerKey: string = key.toLowerCase()
- // if not just a straight string, but an array of strings
- const isList: boolean = obj[key] instanceof Array && key !== 'fields'
-
- // if generating nav for reference fields
- // if isMenu, we're being called from ReferenceMenu in SideBar
- // we loop over content the same way, but we pull out
- // headers and turn those into menu buttons
- if (isMenu) {
-
- // some things are generic, or
- // they can appear multiple times
- if (key === 'example') return null
- if (key === 'fields') return null
- if (key === 'disclaimer') return null
- if (key === 'queryExplorer') return null
-
- // if not just a straight string
- // loop over array and pull out headers
- if (isList) {
- return (
-
- )
- }
-
- // else just return title cased header
- // onClick === _scrollIntoView in ReferenceMenu
- return (
-
- )
- }
-
- const sectionCx: string = cx({
- 'bg-secondary-lightest marg-t-2 marg-b-2 pad-2 pad-b-1': key === 'disclaimer',
- })
-
- const hdrCx: string = cx({
- 'font-size-2': true,
- 'marg-t-3 marg-b-2': key !== 'disclaimer',
- })
-
- // list is maybe a bad term
- // we just mean a non-field Array
- // but sometimes we have literal lists
- if (isList) {
-
- // like so. if marked as an actual list
- // render a unordered list
- if (key === 'ul') {
- return (
-
-
-
-
-
-)
diff --git a/pages/about/status/index.jsx b/pages/about/status/index.jsx
deleted file mode 100644
index 0a862ed6..00000000
--- a/pages/about/status/index.jsx
+++ /dev/null
@@ -1,5 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import ApiStatus from '../../../components/ApiStatus'
-export default () =>
diff --git a/pages/about/updates/index.jsx b/pages/about/updates/index.jsx
deleted file mode 100644
index e719227a..00000000
--- a/pages/about/updates/index.jsx
+++ /dev/null
@@ -1,23 +0,0 @@
-/* @flow */
-
-import React from 'react'
-
-import BlogRoll from '../../../components/BlogRoll'
-import Hero from '../../../components/Hero/index'
-import Layout from '../../../components/Layout'
-
-type PROPS = {
- route: Object;
-};
-
-// homepage
-export default ({ route }: PROPS) => (
-
-
-
-
-)
diff --git a/pages/api_endpoints/_meta.yaml b/pages/api_endpoints/_meta.yaml
deleted file mode 100644
index 51d1573b..00000000
--- a/pages/api_endpoints/_meta.yaml
+++ /dev/null
@@ -1,5 +0,0 @@
-documentTitle: openFDA › Categories
-label: Endpoint Categories
-title: Categories
-description: "This page provides links to all available endpoint categories."
-path: /api_endpoints
\ No newline at end of file
diff --git a/pages/api_endpoints/device/510k/_content.yaml b/pages/api_endpoints/device/510k/_content.yaml
deleted file mode 100644
index 9f339b82..00000000
--- a/pages/api_endpoints/device/510k/_content.yaml
+++ /dev/null
@@ -1,57 +0,0 @@
-- "## About device 510(k)"
-- "The premarket notification dataset contains details about specific products and the original sponsors of premarket notification applications. It also contains administrative and tracking information about the applications and receipt and decision dates."
-- "A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found substantially equivalent through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the “predicate.”"
-- "For additional information, see [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm)."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/device/510k.json` using search parameters for fields specific to the device recalls endpoint."
-- queryExplorer: advisoryCommittee
-- queryExplorer: regulationNumber
-- queryExplorer: topCountryCodes
-- "## Data reference"
-- "### Downloads"
-- "downloads"
-- "### How records are organized"
-- "Example:"
-- example: record
-- "## Anatomy of a response"
-- "This is a simulated openFDA API return for a non-`count` query. It is divided into two high-level sections, `meta` and `results`."
-- example: anatomy
-- "### Meta"
-- "For non-`count` queries, the `meta` section includes a disclaimer, a link to the openFDA data license, and information about the results that follow."
-- example: meta
-- fields:
- - meta.disclaimer
- - meta.license
- - meta.last_updated
- - meta.results.skip
- - meta.results.limit
- - meta.results.total
-- "### Results"
-- "For non-`count` queries, the `results` section includes matching adverse event reports returned by the API."
-- "## Field-by-field reference"
-- fields:
- - k_number
- - clearance_type
- - zip_code
- - decision_code
- - decision_description
- - statement_or_summary
- - date_received
- - third_party_flag
- - state
- - address_1
- - address_2
- - contact
- - country_code
- - city
- - review_advisory_committee
- - advisory_committee
- - advisory_committee_description
- - device_name
- - product_code
- - postal_code
- - applicant
- - decision_date
-- "## OpenFDA"
-- fields:
- - openfda
diff --git a/pages/api_endpoints/device/510k/_examples.json b/pages/api_endpoints/device/510k/_examples.json
deleted file mode 100644
index a04bfbee..00000000
--- a/pages/api_endpoints/device/510k/_examples.json
+++ /dev/null
@@ -1,130 +0,0 @@
-{
- "record": {
- "third_party_flag": "N",
- "city": "PORTLAND",
- "advisory_committee_description": "Immunology",
- "address_1": "217 READ ST.",
- "address_2": "P.O. BOX 9731",
- "statement_or_summary": "",
- "product_code": "KTN",
- "openfda": {
- "device_name": "System, Test, Infectious Mononucleosis",
- "registration_number": [
- "3008776041",
- "1031428",
- "1017835",
- "2030633",
- "8044007",
- "2023336",
- "2027969",
- "9610746",
- "2030538",
- "1641328",
- "2435505",
- "3005641941",
- "2424478",
- "3032705",
- "2025932",
- "1119779",
- "1524213",
- "3010392988",
- "1616487",
- "2950880",
- "3003917514",
- "1319679",
- "1649661",
- "3008741972",
- "2000007960",
- "2250030",
- "2024674",
- "1832216",
- "2246703",
- "2244821",
- "2247139",
- "3002792284",
- "8010096"
- ],
- "fei_number": [
- "",
- "3008776041",
- "1031428",
- "1017835",
- "1000520007",
- "1000119795",
- "1641328",
- "3005641941",
- "2424478",
- "2246703",
- "3002806557",
- "1000135116",
- "1000125596",
- "3001501421",
- "1000122189",
- "3000210620",
- "1119779",
- "1524213",
- "3010392988",
- "1616487",
- "3001451797",
- "3002701146",
- "3003917514",
- "3008741972",
- "2000007960",
- "2250030",
- "2024674",
- "1000136749",
- "1832216",
- "3000107480",
- "2244821",
- "2025932",
- "3002792284"
- ],
- "device_class": "2",
- "medical_specialty_description": "Immunology",
- "regulation_number": "866.5640"
- },
- "zip_code": "04103",
- "applicant": "VENTREX LABORATORIES, INC.",
- "decision_code": "SESE",
- "decision_date": "1987-06-29",
- "country_code": "US",
- "device_name": "VENTRESCREEN (TM) MONO",
- "advisory_committee": "IM",
- "expedited_review_flag": "",
- "contact": "JAMES W CHAMPLIN",
- "state": "ME",
- "review_advisory_committee": "IM",
- "k_number": "K872032",
- "date_received": "1987-05-27",
- "postal_code": "04103",
- "clearance_type": "Traditional",
- "decision_description": "Substantially Equivalent"
- },
- "anatomy": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- },
- "results": [
- { }
- ]
- },
- "meta": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- }
- }
-}
diff --git a/pages/api_endpoints/device/510k/_explorers.yaml b/pages/api_endpoints/device/510k/_explorers.yaml
deleted file mode 100644
index 34df01b6..00000000
--- a/pages/api_endpoints/device/510k/_explorers.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-advisoryCommittee:
- title: One device 510(k) for a CV advisory committee
- description:
- - "This query searches for all records with a particular `advisory_committee`."
- params:
- - "*search* for all records with `advisory_committee` equal to `cv`."
- - "*limit* to 1 record"
- query: 'https://api.fda.gov/device/510k.json?search=advisory_committee:cv&limit=1'
-regulationNumber:
- title: One device 510(k) for a *868.5895* regulation number
- description:
- - "This query searches for records matching a certain search term, and asks for a single one."
- - "See the [reference](/device/510k/reference/) for more fields you can use to narrow searches for device recall."
- params:
- - "*search* for all records with `openfda.regulation_number` equals *868.5895*"
- - "*limit* to 1 record"
- query: 'https://api.fda.gov/device/510k.json?search=openfda.regulation_number:868.5895&limit=1'
-topCountryCodes:
- title: Count of top country codes for device 510(k)
- description:
- - "This query is similar to the prior one, but returns a count of the most frequent country codes."
- - "See the [reference](/device/510k/reference/) for more fields you can use to narrow searches for device recall."
- params:
- - "*search* for all records."
- - count the field `country_code`
- query: 'https://api.fda.gov/device/510k.json?count=country_code'
diff --git a/pages/api_endpoints/device/510k/_fields.yaml b/pages/api_endpoints/device/510k/_fields.yaml
deleted file mode 100644
index 4552b9f0..00000000
--- a/pages/api_endpoints/device/510k/_fields.yaml
+++ /dev/null
@@ -1,292 +0,0 @@
-properties:
- address_1:
- description: "Delivery address of the applicant."
- format:
- is_exact: false
- possible_values:
- type: string
- address_2:
- description: "Delivery address of the applicant."
- format:
- is_exact: false
- possible_values:
- type: string
- advisory_committee:
- description: "Code under which the product was originally classified, based on the product code. This is a historical designation for the group that initially placed a device into Class I, Class II, or Class III following the medical device amendments of May 28, 1976. Two letters indicate the medical specialty panel that was responsible for classifying the product (e.g. GU)."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'AN': "Anesthesiology"
- 'CV': "Cardiovascular"
- 'CH': "Clinical Chemistry"
- 'DE': "Dental"
- 'EN': "Ear, Nose, Throat"
- 'GU': "Gastroenterology, Urology"
- 'HO': "General Hospital"
- 'HE': "Hematology"
- 'IM': "Immunology"
- 'MI': "Microbiology"
- 'NE': "Neurology"
- 'OB': "Obstetrics/Gynecology"
- 'OP': "Ophthalmic"
- 'OR': "Orthopedic"
- 'PA': "Pathology"
- 'PM': "Physical Medicine"
- 'RA': "Radiology"
- 'SU': "General, Plastic Surgery"
- 'TX': "Clinical Toxicology"
- type: string
- advisory_committee_description:
- description: "Full spelling of the Advisory Committee abbreviation (e.g. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee). (note that `&` and `and` have been removed from the descriptions as they conflicted with the API syntax)"
- format:
- is_exact: true
- possible_values:
- type: string
- applicant:
- description: "The manufacturer of record or third party who submits a 510(k) submission. Also known as sponsor. Please note, before Aug 14, 2014, this could be either the manufacturer who submitted the 510k, the third party OR the consultant; after Aug 14, 2014, it is always the manufacturer."
- format:
- is_exact: true
- possible_values:
- type: string
- city:
- description: "City of the delivery address of the applicant."
- format:
- is_exact: true
- possible_values:
- type: string
- clearance_type:
- description: "Denotes the submission method utilized for the submission of the 510(k)."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'traditional': 'Traditional'
- 'special': 'Special'
- 'post': 'Post'
- 'nse': 'NSE'
- 'direct': 'Direct'
- 'track': 'Track'
- 'dual': 'Dual'
- type: string
- contact:
- description: "Per 21 CFR 807.3(e), this is the official correspondent designated by the owner or operator of an establishment as responsible for the following: (1) The annual registration of the establishment and (2) Contact with the Food and Drug Administration for device listing; and (3) Maintenance and submission of a current list of officers and directors to the Food and Drug Administration upon the request of the Commissioner; and (4) The receipt of pertinent correspondence from the Food and Drug Administration directed to and involving the owner or operator and/or any of the firm’s : establishments; and (5) The annual certification of medical device reports required by 804.30 of this chapter or forwarding the certification form to the person designated by the firm as responsible for the certification. For 510ks received before Aug 14, 2014, this could be either the contact from the manufacturer who submitted the 510k, the third party OR the consultant; after Aug 14, 2014, it is always the Applicant (manufacturer)"
- format:
- is_exact: true
- possible_values:
- type: string
- country_code:
- description: "The numeric 2 character code (ISO 3166-1 alpha-2) that designates the country of a postal delivery location (also known as country code)."
- format:
- is_exact: true
- possible_values:
- type: string
- date_received:
- description: "Date that the FDA Document Control Center received the submission."
- format: date
- is_exact: false
- possible_values:
- type: string
- decision_code:
- description: "Four letter codes that denote the specific substantial equivalence decision rendered by FDA on a specific 510(k)."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'SEKD': 'Substantially Equivalent - Kit with Drugs'
- 'SESD': 'Substantially Equivalent with Drug'
- 'SESE': 'Substantially Equivalent'
- 'SESK': 'Substantially Equivalent - Kit'
- 'SESP': 'Substantially Equivalent - Postmarket Surveillance Required'
- 'SESU': 'Substantially Equivalent - With Limitations'
- 'SESR': 'Potential Recall'
- type: string
- decision_date:
- description: "This is the date on which FDA rendered a final decision on a 510(k) submission."
- format: date
- is_exact: false
- possible_values:
- type: string
- decision_description:
- description: "This is the full spelling associated with the abbreviated decision code (e.g. Substantially Equivalent - Postmarket Surveillance Required)."
- format:
- is_exact: false
- possible_values:
- type: string
- device_name:
- description: "This is the proprietary name of the cleared device (trade name)."
- format:
- is_exact: true
- possible_values:
- type: string
- expedited_review_flag:
- description: "Qualifying products are eligible for ‘priority review’ by CDRH in one of four possible review tracks if it is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and is: (1) A breakthrough technology or; (2) there is no alternative means of treatment or diagnosis; or (3) The device offers significant, clinically meaningful advantages over existing approved alternatives; or (4) the availability of the device is in the best interest of patients."
- format:
- is_exact: true
- possible_values:
- type: string
- k_number:
- description: "FDA-assigned premarket notification number, including leading letters. Leading letters “BK” indicates 510(k) clearance, or Premarket Notification, cleared by Center for Biologics Evaluation and Research. Leading letters “DEN” indicates De Novo, or Evaluation of Automatic Class III Designation. Leading letter “K” indicates 510(k) clearance, or Premarket Notification."
- format:
- is_exact: true
- possible_values:
- type: string
- openfda:
- properties:
- device_class:
- description: "A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)"
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "Class I (low to moderate risk): general controls"
- '2': "Class II (moderate to high risk): general controls and special controls"
- '3': "Class III (high risk): general controls and Premarket Approval (PMA)"
- 'U': "Unclassified"
- 'N': "Not classified"
- 'F': "HDE"
- type: string
- device_name:
- description: "This is the proprietary name, or trade name, of the cleared device."
- format:
- is_exact: true
- possible_values:
- type: string
- fei_number:
- items:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- medical_specialty_description:
- description: "Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the “Regulation Medical Specialty” field."
- format:
- is_exact: true
- possible_values:
- type: string
- registration_number:
- items:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- regulation_number:
- items:
- description: "The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device."
- format:
- is_exact: true
- possible_values:
- type: reference
- value:
- name: "CFR database"
- link: "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm"
- type: string
- type: array
- type: object
- postal_code:
- description: "A series of letters and/or digits, sometimes including spaces or punctuation, included in a postal address for the purpose of sorting mail. In the United States, this is a Zip code (below)."
- format:
- is_exact: true
- possible_values:
- type: string
- product_code:
- description: "A three-letter identifier assigned to a device category. Assignment is based upon the medical device classification designated under 21 CFR Parts 862-892, and the technology and intended use of the device. Occasionally these codes are changed over time."
- format:
- is_exact: false
- possible_values:
- type: string
- review_advisory_committee:
- description: "Known as the “510(k) Review Panel” since 2014, this helps define the review division within CDRH in which the 510(k) would be reviewed, if it were reviewed today; this is derived from the procode and is always the same as the “Review Panel” field in the Device Classification database."
- format:
- is_exact: false
- possible_values:
- type: string
- state:
- description: "This is the state of record of U.S. based applicants."
- format:
- is_exact: true
- possible_values:
- type: string
- statement_or_summary:
- description: "A statement or summary can be provided per 21 CFR 807.3(n) and (o). A 510(k) summary, submitted under section 513(i) of the act, of the safety and effectiveness information contained in a premarket notification submission upon which a determination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effectiveness data and information supporting a finding of substantial equivalence, including all adverse safety and effectiveness. The 510(k) Statement is a statement, made under section 513(i) of the act, asserting that all information in a premarket notification submission regarding safety and effectiveness will be made available within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information to be made available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret or confidential commercial information, as defined in 21 CFR 20.61."
- format:
- is_exact: true
- possible_values:
- type: string
- third_party_flag:
- description: "Eligibility for a manufacturer to utilize a contracted Accredited Person in lieu of direct submission to FDA yielding a streamlined review process. Criteria in section 523(b)(3) of 21 U.S.C. 360m(b)."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Y': Yes
- 'N': No
- type: string
- zip_code:
- description: 'Portion of address that designates the U.S. zip code of applicant.'
- format:
- is_exact: false
- possible_values:
- type: string
- meta:
- format:
- type: object
- description: 'This section contains a disclaimer and license information. The field `last_updated` indicates when the data files were exported.'
- possible_values:
- properties:
- type: object
- disclaimer:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Important details notes about openFDA data and limitations of the dataset."
- possible_values:
- license:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Link to a web page with license terms that govern data within openFDA."
- possible_values:
- last_updated:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "The last date when this openFDA endpoint was updated. Note that this does not correspond to the most recent record for the endpoint or dataset. Rather, it is the last time the openFDA API was itself updated."
- possible_values:
- results:
- type: object
- properties:
- skip:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Offset (page) of results, defined by the `skip` [query parameter](/api/)."
- possible_values:
- limit:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Number of records in this return, defined by the `limit` [query parameter](/api/). If there is no `limit` parameter, the API returns one result."
- possible_values:
- total:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Total number of records matching the search criteria."
- possible_values:
-type: object
diff --git a/pages/api_endpoints/device/510k/_infographics.yaml b/pages/api_endpoints/device/510k/_infographics.yaml
deleted file mode 100644
index bdf197ea..00000000
--- a/pages/api_endpoints/device/510k/_infographics.yaml
+++ /dev/null
@@ -1,34 +0,0 @@
-- title: "Device 510(k) by advisory committee"
- short: "By advisory committee"
- description:
- - "The advisory committee is the code under which the product was originally classified, based on the product code. This is a historical designation for the group that initially placed a device into Class I, Class II, or Class III following the medical device amendments of May 28, 1976."
- countParam: "advisory_committee_description"
- filters:
- - title: "All 510(k)"
- searchParam: ""
- - title: "Clearance type *Traditional*"
- searchParam: "clearance_type:Traditional"
- - title: "Decision type is *Substantially Equivalent*"
- searchParam: "decision_description:Substantially+Equivalent"
- - title: "Device class *I* (generally less risk to patients)"
- searchParam: "openfda.device_class:1"
- - title: "Device class III (generally more risk to patients)"
- searchParam: "openfda.device_class:1"
- filterByDate: false
- type: Bar
-- title: "Device 510(k) by country"
- short: "By country"
- description:
- - "The country listed on the postal delivery address of the applicant."
- countParam: "country_code"
- filters:
- - title: "All 510(k)"
- searchParam: ""
- - title: "All 510(k) except *US*"
- searchParam: "country_code:(NOT US)"
- - title: "Advisory committee set to *Anesthesiology* and Country not *US*"
- searchParam: "advisory_committee:AN+AND+country_code:(NOT US)"
- - title: "Device class *III* and *Not US*"
- searchParam: "openfda.device_class:3+AND+country_code:(NOT US)"
- filterByDate: false
- type: Bar
diff --git a/pages/api_endpoints/device/510k/_meta.yaml b/pages/api_endpoints/device/510k/_meta.yaml
deleted file mode 100644
index 32873498..00000000
--- a/pages/api_endpoints/device/510k/_meta.yaml
+++ /dev/null
@@ -1,11 +0,0 @@
-type: endpoint
-documentTitle: openFDA › Device › 510(k) API
-label: Device 510(k)
-title: Device 510(k)
-description: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.
-datasets:
- - 510k
-path: /api_endpoints/device/510k
-api_path: /device/510k
-start: 19760101
-status: deviceclearance
diff --git a/pages/api_endpoints/device/510k/index.jsx b/pages/api_endpoints/device/510k/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/device/510k/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/device/_content.yaml b/pages/api_endpoints/device/_content.yaml
deleted file mode 100644
index c739470e..00000000
--- a/pages/api_endpoints/device/_content.yaml
+++ /dev/null
@@ -1,32 +0,0 @@
-- url: /device/event/
- title: Device adverse events
- description:
- - "Reports of serious injuries, deaths, malfunctions, and other undesirable effects associated with the use of medical devices."
-- url: /device/classification/
- title: Device classification
- description:
- - "Medical device names, their associated product codes, their medical specialty areas (panels) and their classification."
-- url: /device/510k/
- title: Device 510(k) clearances
- description:
- - "A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device."
-- url: /device/pma/
- title: Device PMA
- description:
- - "Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices."
-- url: /device/registrationlisting/
- title: Device registrations and listings
- description:
- - "The registration and listing dataset contains the location of medical device establishments and the devices manufactured at those establishments."
-- url: /device/recall/
- title: Device recalls
- description:
- - "A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health."
-- url: /device/enforcement/
- title: Device recall enforcement reports
- description:
- - "Medical device product recall enforcement reports."
-- url: /device/udi/
- title: Unique Device Identifier
- description:
- - "Global Unique Device Identification Database (GUIDID) Device Identification dataset."
diff --git a/pages/api_endpoints/device/_meta.yaml b/pages/api_endpoints/device/_meta.yaml
deleted file mode 100644
index 62180d3f..00000000
--- a/pages/api_endpoints/device/_meta.yaml
+++ /dev/null
@@ -1,6 +0,0 @@
-documentTitle: openFDA › Devices
-label: API categories
-title: Devices
-description: "The U.S. Food and Drug Administration (FDA) regulates medical devices in the United States. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers and laser surgical devices."
-path: /api_endpoints/device/
-type: noun
diff --git a/pages/api_endpoints/device/_template.jsx b/pages/api_endpoints/device/_template.jsx
deleted file mode 100644
index b9e477f8..00000000
--- a/pages/api_endpoints/device/_template.jsx
+++ /dev/null
@@ -1,2 +0,0 @@
-import React from 'react'
-export default (props) => props.children
diff --git a/pages/api_endpoints/device/classification/_content.yaml b/pages/api_endpoints/device/classification/_content.yaml
deleted file mode 100644
index 6f57dd4d..00000000
--- a/pages/api_endpoints/device/classification/_content.yaml
+++ /dev/null
@@ -1,39 +0,0 @@
-- "## About device classification"
-- "The U.S. Food and Drug Administration (FDA) regulates medical devices in the United States. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines, and medical lasers."
-- "The Product Classification dataset contains medical device names, their associated product codes, their medical specialty areas (panels) and their classification. The name and product code identify the generic category of a device for FDA. The product code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892."
-- "The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device."
-- "For additional information, see [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm)."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/device/classification.json` using search parameters for fields specific to the device classification endpoint."
-- queryExplorer: oneDevice
-- queryExplorer: nob
-- queryExplorer: topFei
-- "## Data reference"
-- "### Downloads"
-- "downloads"
-- "## How records are organized"
-- example: header
-- example: openfda
-- "## Results"
-- "For non-`count` queries, the `results` section includes matching device classification records returned by the API."
-- "## Field-by-field reference"
-- fields:
- - regulation_number
- - life_sustain_support_flag
- - definition
- - review_code
- - submission_type_id
- - third_party_flag
- - implant_flag
- - medical_specialty
- - medical_specialty_description
- - device_class
- - device_name
- - product_code
- - review_panel
- - unclassified_reason
- - gmp_exempt_flag
-- "### OpenFDA"
-- "The `openfda` section of each document is determined by looking at the product_code value."
-- fields:
- - openfda
diff --git a/pages/api_endpoints/device/classification/_examples.json b/pages/api_endpoints/device/classification/_examples.json
deleted file mode 100644
index 8e31e46e..00000000
--- a/pages/api_endpoints/device/classification/_examples.json
+++ /dev/null
@@ -1,37 +0,0 @@
-{
- "header": {
- "definition": "",
- "device_class": "1",
- "device_name": "Dispenser, Mercury And/Or Alloy",
- "gmp_exempt_flag": "N",
- "implant_flag": "N",
- "life_sustain_support_flag": "N",
- "medical_specialty": "DE",
- "medical_specialty_description": "Dental",
- "product_code": "EHE",
- "regulation_number": "872.3080",
- "review_code": "",
- "review_panel": "DE",
- "submission_type_id": "4",
- "third_party_flag": "N",
- "unclassified_reason": ""
- },
- "openfda": {
- "fei_number": [
- "3010811185",
- "3008069117",
- "3009171220",
- "2182762"
- ],
- "k_number": [
- "K771396",
- "K771749"
- ],
- "registration_number": [
- "3010811185",
- "8043296",
- "3009171220",
- "2182762"
- ]
- }
-}
\ No newline at end of file
diff --git a/pages/api_endpoints/device/classification/_explorers.yaml b/pages/api_endpoints/device/classification/_explorers.yaml
deleted file mode 100644
index e6146cd2..00000000
--- a/pages/api_endpoints/device/classification/_explorers.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-oneDevice:
- title: One device classification
- description:
- - This query searches for all records with a particular `regulation_number`.
- params:
- - search for all records with `regulation_number` equal to `872.6855`.
- - limit to 1 record.
- query: 'https://api.fda.gov/device/classification.json?search=regulation_number:872.6855&limit=1'
-nob:
- title: One classification for a NOB product code
- description:
- - search for all records with `product_code` equals `NOB`.
- - See the [reference](/device/classification/reference/) for more fields you can use to count and understand the nature of device classification.
- params:
- - search for all records with `product_code` equals `LWP`.
- - limit to 1 record.
- query: 'https://api.fda.gov/device/classification.json?search=product_code:NOB&limit=1'
-topFei:
- title: Count of top Facility Establishment Identifiers (FEI) for device classifications.
- description:
- - This query is similar to the prior one, but returns a count of the most frequent FEI numbers.
- - See the [reference](/device/classification/reference/) for more fields you can use to count and understand the nature of device classification.
- params:
- - search for all records.
- - count the field `openfda.fei_number`
- query: 'https://api.fda.gov/device/classification.json?count=openfda.fei_number'
\ No newline at end of file
diff --git a/pages/api_endpoints/device/classification/_fields.yaml b/pages/api_endpoints/device/classification/_fields.yaml
deleted file mode 100644
index 0bd7cf3c..00000000
--- a/pages/api_endpoints/device/classification/_fields.yaml
+++ /dev/null
@@ -1,175 +0,0 @@
-properties:
- definition:
- description: "Compositional definition of a medical device, based on the input of nomenclature experts, incorporating the definition of components of a device."
- format:
- is_exact: false
- possible_values:
- type: string
- device_class:
- description: "A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "Class I (low to moderate risk): general controls"
- '2': "Class II (moderate to high risk): general controls and special controls"
- '3': "Class III (high risk): general controls and Premarket Approval (PMA)"
- 'U': "Unclassified"
- 'N': "Not classified"
- 'F': "HDE"
- type: string
- device_name:
- description: "This is the proprietary name, or trade name, of the cleared device"
- format:
- is_exact: true
- possible_values:
- type: string
- gmp_exempt_flag:
- description: "An indication the device is exempt from Good Manufacturing Processes CFR 820. U.S. zip code of the Applicant. See [here](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm) for more detail."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Y': "Exempt due to Good Manufacturing Practice (GMP)/Quality System"
- 'N': "Not exempt due to Good Manufacturing Practice (GMP)/Quality System"
- type: string
- implant_flag:
- description: "An indicator that the device is placed into a surgically or naturally formed cavity of the human body. Intended to remain implanted for 30 days or more; or the Commissioner makes a determination (that the device is to be considered implanted)."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Y': "Device is implantable"
- 'N': "Device is not implantable"
- type: string
- life_sustain_support_flag:
- description: "An indicator that the device is essential to, or yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Y': "Device is used for life sustaining purposes."
- 'N': "Device is not used for life sustaining purposes"
- type: string
- medical_specialty:
- description: "Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the “Regulation Medical Specialty” field. Two letters indicating the medical specialty panel responsible for reviewing the product. See [link](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051668.htm#medicalspecialty) for further detail."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'AN': "Anesthesiology"
- 'CV': "Cardiovascular"
- 'CH': "Clinical Chemistry"
- 'DE': "Dental"
- 'EN': "Ear, Nose, Throat"
- 'GU': "Gastroenterology, Urology"
- 'HO': "General Hospital"
- 'HE': "Hematology"
- 'IM': "Immunology"
- 'MI': "Microbiology"
- 'NE': "Neurology"
- 'OB': "Obstetrics/Gynecology"
- 'OP': "Ophthalmic"
- 'OR': "Orthopedic"
- 'PA': "Pathology"
- 'PM': "Physical Medicine"
- 'RA': "Radiology"
- 'SU': "General, Plastic Surgery"
- 'TX': "Clinical Toxicology"
- type: string
- medical_specialty_description:
- description: "Same as above but with the codes replaced with a human readable description. Note that & and and have been removed from the descriptions as they conflicted with the API syntax)."
- format:
- is_exact: true
- possible_values:
- type: string
- openfda:
- properties:
- fei_number:
- items:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- registration_number:
- items:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- type: object
- product_code:
- description: "A three-letter identifier assigned to a device category. Assignment is based upon the medical device classification designated under 21 CFR Parts 862-892, and the technology and intended use of the device. Occasionally these codes are changed over time."
- format:
- is_exact: false
- possible_values:
- type: string
- regulation_number:
- description: "The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device."
- format:
- is_exact: true
- possible_values:
- type: reference
- value:
- name: "CFR database"
- link: "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm"
- type: string
- review_code:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- review_panel:
- description: "Known as the “510(k) Review Panel” since 2014, this helps define the review division within CDRH in which the 510(k) would be reviewed, if it were reviewed today; this is derived from the procode and is always the same as the “Review Advisory Committee” field in the 510(k) database."
- format:
- is_exact: false
- possible_values:
- type: string
- submission_type_id:
- description: "The submission type (510(k), PMA, 510(k) Exempt) to which a product code is limited, or “Contact ODE” if its limitations (if any) are undetermined."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "510(K)"
- '2': "PMA"
- '3': "Contact ODE"
- '4': "510(K) Exempt"
- type: string
- third_party_flag:
- description: "Eligibility for a manufacturer to utilize a contracted Accredited Person in lieu of direct submission to FDA. By law, FDA must in turn issue a final determination within 30 days after receiving the recommendation of an Accredited Person (yielding a streamlined review process)."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Y': "Device is a candidate for a third party review program"
- 'N': "Device is not a candidate for a third party review program"
- type: string
- unclassified_reason:
- description: "This indicates the reason why a device is unclassified (e.g. Pre-Amendment)."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "Pre-Amendment"
- '2': "IDE"
- '3': "For Export Only"
- '4': "Unknown"
- '5': "Guidance Under Development"
- '6': "Enforcement Discretion"
- '7': "Not FDA Regulated"
- type: string
-type: object
diff --git a/pages/api_endpoints/device/classification/_infographics.yaml b/pages/api_endpoints/device/classification/_infographics.yaml
deleted file mode 100644
index 526f796a..00000000
--- a/pages/api_endpoints/device/classification/_infographics.yaml
+++ /dev/null
@@ -1,44 +0,0 @@
-- title: "Device classifications by medical specialty"
- short: "By medical specialty"
- description:
- - "Most medical devices can be classified by finding the matching description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892."
- - "FDA has classified and described over 1,700 distinct types of devices and organized them in the CFR into 16 medical specialty `panels` such as `Cardiovascular` devices or `Ear, Nose, and Throat` devices. These panels are found in Parts 862 through 892 in the CFR. For each of the devices classified by the FDA the CFR gives a general description including the intended use, the class to which the device belongs (i.e., Class I, II, or III), and information about marketing requirements. Your device should meet the definition in a classification regulation contained in 21 CFR 862-892."
- countParam: "medical_specialty_description.exact"
- filters:
- - title: "All device classifications"
- searchParam: ""
- - title: "Devices with the word implant in the name"
- searchParam: "device_name:implant"
- - title: "Device class I or II"
- searchParam: "device_class:(1 OR 2)"
- filterByDate: false
- type: Bar
-- title: "Device classifications by regulation numbers"
- short: "Regulation number"
- description:
- - "Each device has a 7-digit number associated with it, e.g. [880.2920](http://www.ecfr.gov/cgi-bin/text-idx?SID=aa9e943fbab96dade45ed7e2a203271e&mc=true&node=se21.8.880_12920&rgn=div8) - Clinical Mercury Thermometer. The regulation will, among other things, specify how to identify the device and under which classification the device should fall."
- - "[Here]('http://www.ecfr.gov/cgi-bin/text-idx?SID=f5e72c39f47ecb6121143e01ae6a2428&mc=true&tpl=/ecfrbrowse/Title21/21cfrv8_02.tpl#0') is a link to the most up-to-date version of CFR Title 21, parts 800-1299, which is where medical device regulation is spelled out."
- countParam: "regulation_number.exact"
- filters:
- - title: "All Classifications"
- searchParam: ""
- - title: "Indicated as providing life sustaining support"
- searchParam: "life_sustain_support_flag:Y"
- - title: "Indicated as a non-implant"
- searchParam: "implant_flag:N"
- - title: "Third Party Flag set to N"
- searchParam: "third_party_flag:N"
- filterByDate: false
- type: Bar
-
-
-
-
-
-
-
-
-
-
-
-
diff --git a/pages/api_endpoints/device/classification/_meta.yaml b/pages/api_endpoints/device/classification/_meta.yaml
deleted file mode 100644
index 9c7f36fb..00000000
--- a/pages/api_endpoints/device/classification/_meta.yaml
+++ /dev/null
@@ -1,11 +0,0 @@
-type: endpoint
-documentTitle: openFDA › Device › Classification
-label: Device classification
-title: Device Classification
-description: The U.S. Food and Drug Administration (FDA) regulates medical devices in the United States. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines, and medical lasers.
-endpoint: device/classification
-datasets:
-path: /api_endpoints/device/classification
-api_path: /device/classification
-start:
-status: deviceclass
\ No newline at end of file
diff --git a/pages/api_endpoints/device/classification/index.jsx b/pages/api_endpoints/device/classification/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/device/classification/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/device/enforcement/_content.yaml b/pages/api_endpoints/device/enforcement/_content.yaml
deleted file mode 100644
index 5fef4444..00000000
--- a/pages/api_endpoints/device/enforcement/_content.yaml
+++ /dev/null
@@ -1,78 +0,0 @@
-- "## About device recalls and enforcement reports"
-- "Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA). Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or civil actions, especially when the product has been widely distributed."
-- "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
-- "## Enforcement reports"
-- "An enforcement report contains information on actions taken in connection with FDA regulatory activities. The data served by this API endpoint includes enforcement reports about device product recalls."
-- "This API should not be used as a method to collect data to issue alerts to the public. FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. Subscribe to this Recall/Safety Alert feed here."
-- "Whereas not all recalls are announced in the media or on our recall press release page all FDA-monitored recalls go into FDA’s Enforcement Report once they are classified according to the level of hazard involved. For more information, see FDA 101: Product Recalls from First Alert to Effectiveness Checks."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/device/enforcement.json` using search parameters for fields specific to the device enforcement endpoint."
-- queryExplorer: oneReport
-- queryExplorer: hazard
-- queryExplorer: voluntaryVsMandated
-- "## Data reference"
-- "The openFDA device enforcement reports API returns data from the [FDA Recall Enterprise System (RES)](/data/res/), a database that contains information on recall event information submitted to FDA. Currently, this data covers publically releasable records from 2004-present. The data is updated weekly."
-- "The procedures followed to input recall information into RES when FDA learns of a recall event are outlined in [Chapter 7 of FDA’s Regulatory Procedure Manual](http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm177304.htm). The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters."
-- disclaimer:
- - "This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall. FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. [Subscribe to this Recall/Safety Alert feed here](http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Recalls/rss.xml)."
- - "Further, FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports."
-- "When necessary, the FDA will make corrections or changes to recall information previously disclosed in a past Enforcement Report for various reasons. For instance, the firm may discover that the initial recall should be expanded to include more batches or lots of the same recalled product than formerly reported. For more information about corrections or changes implemented, please refer to the Enforcement Report’s [Changes to Past Enforcement Reports” page](http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm345487.htm)."
-- "### What are enforcement reports?"
-- "An enforcement report contains information on actions taken in connection with FDA regulatory activities. The data served by this API endpoint includes enforcement reports about drug product recalls."
-- "Whereas not all recalls are announced in the media or on [FDA’s Recalls press release page](http://www.fda.gov/Safety/recalls/default.htm), all recalls montiored by FDA are included in [FDA’s weekly Enforcement Report](http://www.fda.gov/%20Safety/Recalls/EnforcementReports/default.htm) once they are classified according to the level of hazard involved."
-- "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
-- "### Downloads"
-- "downloads"
-- "### Anatomy of a response"
-- "This is a simulated openFDA API return for a non-`count` query. It is divided into two high-level sections, `meta` and `results`."
-- example: anatomy
-- "### Meta"
-- "For non-`count` queries, the `meta` section includes a disclaimer, a link to the openFDA data license, and information about the results that follow."
-- example: meta
-- fields:
- - meta.disclaimer
- - meta.license
- - meta.last_updated
- - meta.results.skip
- - meta.results.limit
- - meta.results.total
-- "### Results"
-- "For non-`count` queries, the `results` section includes matching enforcement report records returned by the API, each of which has a set of fields describing the device product recall."
-- "The data format of RES enforcement reports changed in June 2012. In openFDA API results, reports from before that time do not contain the following fields:"
-- ul:
- - "`event_id`"
- - "`status`"
- - "`city`"
- - "`state`"
- - "`country`"
- - "`voluntary_mandated`"
- - "`initial_firm_notification`"
- - "`recall_initiation_date`"
-- "## Field-by-field reference"
-- "### Enforcement report"
-- example: result
-- fields:
- - recalling_firm
- - classification
- - status
- - distribution_pattern
- - product_description
- - code_info
- - reason_for_recall
- - product_quantity
- - voluntary_mandated
- - report_date
- - recall_initiation_date
- - initial_firm_notification
- - recall_number
- - event_id
- - product_type
-- "### Geographic data"
-- fields:
- - city
- - state
- - country
-- "### OpenFDA fields"
-- "For more information about the `openfda` section, see the [API reference](/api/reference/)."
-- "Device product recall enforcement reports will always have an empty `openfda` section."
-- "datasets"
diff --git a/pages/api_endpoints/device/enforcement/_examples.json b/pages/api_endpoints/device/enforcement/_examples.json
deleted file mode 100644
index 04823357..00000000
--- a/pages/api_endpoints/device/enforcement/_examples.json
+++ /dev/null
@@ -1,49 +0,0 @@
-{
- "anatomy": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- },
- "results": [
- {}
- ]
- },
- "meta": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- }
- },
- "result": {
- "reason_for_recall": "One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.",
- "status": "Ongoing",
- "distribution_pattern": "Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.",
- "product_quantity": "18 devices",
- "recall_initiation_date": "20120716",
- "state": "TX",
- "event_id": "62561",
- "product_type": "Devices",
- "product_description": "djo surgical Screw 6.5 mm, Sz 25mm, low profile.\n\nProduct is intended for the fixation of the acetabular shell or fracture repair",
- "country": "US",
- "city": "Austin",
- "recalling_firm": "Encore Medical, Lp",
- "report_date": "20120815",
- "voluntary_mandated": "Voluntary: Firm Initiated",
- "classification": "Class II",
- "code_info": "Lot 007A1037, Ref 010-55-25.",
- "openfda": {},
- "initial_firm_notification": "Letter"
- }
-}
diff --git a/pages/api_endpoints/device/enforcement/_explorers.yaml b/pages/api_endpoints/device/enforcement/_explorers.yaml
deleted file mode 100644
index 605c7dbf..00000000
--- a/pages/api_endpoints/device/enforcement/_explorers.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-oneReport:
- title: One enforcement report
- description:
- - "This query searches for all records in a certain date range, and asks for a single one."
- - "See the [reference](/device/enforcement/reference/) for more about report_date. Brackets `[ ]` are used to specify a range for date, number, or string fields."
- params:
- - "Search for all records with report_date between Jan 01, 2004 and Dec 31, 2013."
- - "Limit to 1 record."
- query: 'https://api.fda.gov/device/enforcement.json?search=report_date:[20040101+TO+20131231]&limit=1'
-hazard:
- title: One enforcement report of a certain health hazard class
- description:
- - "This query searches records of a certain health hazard, and returns a single record."
- - 'Double quotation marks `" "` surround phrases that must match exactly. The plus sign + is used in place of a space character ` `.'
- params:
- - "Search for all records where classification (health hazard level) was Class III."
- - "Limit to 1 record."
- query: 'https://api.fda.gov/device/enforcement.json?search=classification:"Class+III"&limit=1'
-voluntaryVsMandated:
- title: "Count of voluntary vs. mandated enforcement reports"
- description:
- - "The vast majority of recalls are firm-initiated. This query searches the endpoint for all records, and tells the API to count how many enforcement reports were for voluntary vs. FDA-mandated recalls."
- - "The suffix .exact is required by openFDA to count the unique full phrases in the field voluntary_mandated. Without it, the API will count each word in that field individually—Firm Initiated would be counted as separate values, Firm and Initiated."
- params:
- - "Count the field `voluntary_mandated` (type of recall)."
- query: 'https://api.fda.gov/device/enforcement.json?count=voluntary_mandated.exact'
diff --git a/pages/api_endpoints/device/enforcement/_fields.yaml b/pages/api_endpoints/device/enforcement/_fields.yaml
deleted file mode 100644
index bc001ff0..00000000
--- a/pages/api_endpoints/device/enforcement/_fields.yaml
+++ /dev/null
@@ -1,407 +0,0 @@
-properties:
- address_1:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- address_2:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- center_classification_date:
- description:
- format: date
- is_exact: false
- possible_values:
- type: string
- city:
- description: "The city in which the recalling firm is located."
- format:
- is_exact: true
- possible_values:
- type: string
- classification:
- description: "Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- "Class I": "Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve."
- "Class II": "Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations."
- "Class III": "Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food."
- type: string
- code_info:
- description: "A list of all lot and/or serial numbers, product numbers, packer or manufacturer numbers, sell or use by dates, etc., which appear on the product or its labeling."
- format:
- is_exact: false
- possible_values:
- type: string
- country:
- description: "The country in which the recalling firm is located."
- format:
- is_exact: true
- possible_values:
- type: string
- distribution_pattern:
- description: "General area of initial distribution such as, “Distributors in 6 states: NY, VA, TX, GA, FL and MA; the Virgin Islands; Canada and Japan”. The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included."
- format:
- is_exact: false
- possible_values:
- type: string
- event_id:
- description: "A numerical designation assigned by FDA to a specific recall event used for tracking purposes."
- format: int64
- is_exact: false
- possible_values:
- type: string
- initial_firm_notification:
- description: "The method(s) by which the firm initially notified the public or their consignees of a recall. A consignee is a person or firm named in a bill of lading to whom or to whose order the product has or will be delivered."
- format:
- is_exact: true
- possible_values:
- type: string
- more_code_info:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- openfda:
- properties:
- application_number:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- brand_name:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- dosage_form:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- generic_name:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- is_original_packager:
- description:
- format:
- is_exact: true
- possible_values:
- type: boolean
- manufacturer_name:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- nui:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- original_packager_product_ndc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- package_ndc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- pharm_class_cs:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- pharm_class_epc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- pharm_class_moa:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- pharm_class_pe:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- product_ndc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- product_type:
- items:
- description: "The type of product being recalled. For device queries, this will always be `Devices`."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- "Drugs": "The recalled product is a drug product."
- "Devices": "The recalled product is a device product."
- "Food": "The recalled product is a food product."
- type: string
- type: array
- route:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- rxcui:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- rxstring:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- rxtty:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- spl_id:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- spl_set_id:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- substance_name:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- unii:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- upc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- type: object
- product_code:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- product_description:
- description: "Brief description of the product being recalled."
- format:
- is_exact: false
- possible_values:
- type: string
- product_quantity:
- description: "The amount of defective product subject to recall."
- format:
- is_exact: false
- possible_values:
- type: string
- product_type:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- reason_for_recall:
- description: "Information describing how the product is defective and violates the FD&C Act or related statutes."
- format:
- is_exact: false
- possible_values:
- type: string
- recall_initiation_date:
- description: "Date that the firm first began notifying the public or their consignees of the recall."
- format: date
- is_exact: false
- possible_values:
- type: string
- recall_number:
- description: "A numerical designation assigned by FDA to a specific recall event used for tracking purposes."
- format:
- is_exact: true
- possible_values:
- type: string
- recalling_firm:
- description: "The firm that initiates a recall or, in the case of an FDA requested recall or FDA mandated recall, the firm that has primary responsibility for the manufacture and (or) marketing of the product to be recalled."
- format:
- is_exact: true
- possible_values:
- type: string
- report_date:
- description: "Date that the FDA issued the enforcement report for the product recall."
- format: date
- is_exact: false
- possible_values:
- type: string
- state:
- description: "The U.S. state in which the recalling firm is located."
- format:
- is_exact: true
- possible_values:
- type: string
- status:
- description:
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- "On-Going": "A recall which is currently in progress."
- "Completed": "The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections."
- "Terminated": "FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard."
- "Pending": "Actions that have been determined to be recalls, but that remain in the process of being classified."
- type: string
- termination_date:
- description:
- format: date
- is_exact: false
- possible_values:
- type: string
- voluntary_mandated:
- description: "Describes who initiated the recall. Recalls are almost always voluntary, meaning initiated by a firm. A recall is deemed voluntary when the firm voluntarily removes or corrects marketed products or the FDA requests the marketed products be removed or corrected. A recall is mandated when the firm was ordered by the FDA to remove or correct the marketed products, under section 518(e) of the FD&C Act, National Childhood Vaccine Injury Act of 1986, 21 CFR 1271.440, Infant Formula Act of 1980 and its 1986 amendments, or the Food Safety Modernization Act (FSMA)."
- format:
- is_exact: true
- possible_values:
- type: string
- meta:
- format:
- type: object
- description: 'This section contains a disclaimer and license information. The field `last_updated` indicates when the data files were exported.'
- possible_values:
- properties:
- type: object
- disclaimer:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Important details notes about openFDA data and limitations of the dataset."
- possible_values:
- license:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Link to a web page with license terms that govern data within openFDA."
- possible_values:
- last_updated:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "The last date when this openFDA endpoint was updated. Note that this does not correspond to the most recent record for the endpoint or dataset. Rather, it is the last time the openFDA API was itself updated."
- possible_values:
- results:
- type: object
- properties:
- skip:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Offset (page) of results, defined by the `skip` [query parameter](/api/)."
- possible_values:
- limit:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Number of records in this return, defined by the `limit` [query parameter](/api/). If there is no `limit` parameter, the API returns one result."
- possible_values:
- total:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Total number of records matching the search criteria."
- possible_values:
-type: object
diff --git a/pages/api_endpoints/device/enforcement/_infographics.yaml b/pages/api_endpoints/device/enforcement/_infographics.yaml
deleted file mode 100644
index a7ba1c9b..00000000
--- a/pages/api_endpoints/device/enforcement/_infographics.yaml
+++ /dev/null
@@ -1,36 +0,0 @@
-- title: "Device recall enforcement reports since 2012"
- short: "Enforcement reports over time"
- description:
- - "This is the openFDA API endpoint for all device product recalls monitored by the FDA. When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public."
- - "Recalls are almost always voluntary, meaning a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request or order a recall. But in every case, FDA's role is to oversee a company's strategy, classify the recalled products according to the level of hazard involved, and assess the adequacy of the recall. Recall information is posted in the Enforcement Reports once the products are classified."
- - "Important note: FDA is working to consolidate medical device recall information."
- countParam: "report_date"
- filters:
- - title: "All device product enforcement reports"
- searchParam: ""
- - title: 'Recalls mentioning "catheter"'
- searchParam: 'reason_for_recall:"catheter"'
- type: Line
- dateConstraint: false
-- title: "The vast majority of device product recalls are voluntary"
- short: "Who initiates?"
- description:
- - "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
- countParam: "voluntary_mandated.exact"
- filters:
- - title: "All device product enforcement reports"
- searchParam: ""
- type: Donut
- dateConstraint: false
-- title: "Most device product recalls are Class II"
- short: "Seriousness"
- description:
- - "Recalls are classified into three categories: Class I, a dangerous or defective product that predictably could cause serious health problems or death, Class II, meaning that the product might cause a temporary health problem, or pose only a slight threat of a serious nature, and Class III, a product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws."
- countParam: "classification.exact"
- filters:
- - title: "All device product enforcement reports"
- searchParam: ""
- - title: 'Recalls mentioning "catheter"'
- searchParam: 'reason_for_recall:"catheter"'
- type: Donut
- dateConstraint: false
diff --git a/pages/api_endpoints/device/enforcement/_meta.yaml b/pages/api_endpoints/device/enforcement/_meta.yaml
deleted file mode 100644
index c070d5d6..00000000
--- a/pages/api_endpoints/device/enforcement/_meta.yaml
+++ /dev/null
@@ -1,12 +0,0 @@
-documentTitle: openFDA › Devices › Recall enforcement reports API
-label: Device recall enforcement reports
-title: Device Recall Enforcement Reports
-description: "Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA)."
-datasets:
- - RES
-path: /api_endpoints/device/enforcement
-api_path: /device/enforcement
-start: 20090101
-status: deviceenforcement
-type: endpoint
-dateConstraintKey: termination_date
diff --git a/pages/api_endpoints/device/enforcement/index.jsx b/pages/api_endpoints/device/enforcement/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/device/enforcement/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/device/event/_content.yaml b/pages/api_endpoints/device/event/_content.yaml
deleted file mode 100644
index 312ede26..00000000
--- a/pages/api_endpoints/device/event/_content.yaml
+++ /dev/null
@@ -1,205 +0,0 @@
-- "## About device adverse events"
-- "The U.S. Food and Drug Administration (FDA) regulates medical devices in the United States. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines, and medical lasers."
-- "An adverse event report is submitted to the FDA to report serious events or undesirable experiences associated with the use of a medical device."
-- "### Adverse event reports"
-- "Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and by voluntary reporters (such as health care professionals, patients, and consumers)."
-- "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources."
-- "See the [MAUDE dataset page](/data/maude/) for more details."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/device/event.json` using search parameters for fields specific to the device adverse events endpoint."
-- queryExplorer: oneReport
-- queryExplorer: genericName
-- queryExplorer: topEvents
-- "## Data reference"
-- "The openFDA device adverse event API returns data from [Manufacturer and User Facility Device Experience (MAUDE)](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm), an FDA dataset that contains medical device adverse event reports submitted by mandatory reporters—manufacturers, importers and device user facilities—and voluntary reporters such as health care professionals, patients, and consumers. Currently, this data covers publically releasable records submitted to the FDA from about 1992 to the present. The data is updated weekly."
-- "Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products."
-- disclaimer:
- - "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources."
-- "See the [MAUDE dataset page](/data/maude/) for more details."
-- "## How records are organized"
-- "Device adverse event reports vary significantly, depending on who initially reported the event, what kind of event was reported, and whether there were follow-up reports. Some reports come directly from user facilities (like hospitals) or device importers (distributors), while others come directly from manufacturers. Some involve adverse reactions in patients, while others are reports of defects that did not result in such adverse reactions."
-- "Records served by the openFDA device adverse events endpoint loosely reflect field organization found in the [forms used by manufacturers and members of the public](http://www.fda.gov/Safety/MedWatch/HowtoReport/DownloadForms/default.htm) to report these events. Since reports may come from manufacturers, user facilities, distributors, and voluntary sources (such as patients and physicians) who are subject to different reporting requirements, the collected data in the adverse event system may not always capture every field and should not be interpreted as incomplete."
-- "**Patients and devices.**"
-- "Reports may involve more than one device, and more than one patient. Each device, and each patient, is identified in the report by a sequence number, beginning with `1`."
-- ul:
- - "The `device` section in a result has one JSON object for each device."
- - "Each device is identified by a number in the field `device.device_sequence_number`."
- - "The other fields describe that device."
-- ul:
- - "The `patient` section in a result has one JSON object for each patient."
- - "Each patient identified by a number in the field `patient.patient_sequence_number`."
- - "The other fields describe outcomes and treatments for that patient."
-- ul:
- - "The `mdr_text` section, which has narrative descriptions of the adverse event or problem report, links these descriptions to patient outcomes by way of the same patient sequence number"
- - "Here the sequence number is in the field `mdr_text.patient_sequence_number`."
- - "Even in reports that did not involve any patient, the general device problem description is still associated with a “patient” with `patient_sequence_number` `1`."
-- "### Downloads"
-- "downloads"
-- "## Field-by-field reference"
-- "### Event"
-- "These fields describe the general nature of the adverse event. For example, whether it was a device malfunction or defect, whether there were patients involved, who reported the event, and so on."
-- fields:
- - adverse_event_flag
- - product_problem_flag
- - date_of_event
- - date_report
- - date_received
- - device_date_of_manufacturer
- - event_type
- - number_devices_in_event
- - number_patients_in_event
- - previous_use_code
- - remedial_action
- - removal_correction_number
- - report_number
- - single_use_flag
-- "### Source"
-- "These fields describe the source and initial reporter of the adverse event report."
-- fields:
- - report_source_code
- - health_professional
- - reporter_occupation_code
- - initial_report_to_fda
- - reprocessed_and_reused_flag
-- "### Device"
-- "If there were devices listed in the adverse event report, there will be a `device` section, consisting of a list of devices. Each object in the `device` section may consist of many of the following fields."
-- example: device
-- "The first field is a record-local index for the particular device; it is also used to link this device information to narrative (text) descriptions in the `mdr_text` section."
-- fields:
- - device.device_sequence_number
- - device.device_event_key
- - device.date_received
-- "### Identifcation"
-- "Each device has fields that can be used to uniquely identify it."
-- fields:
- - device.brand_name
- - device.generic_name
- - device.device_report_product_code
-- "**Device model and catalog numbers**"
-- "If available, these values should be recorded exactly as they appear on the device or device labeling, including spaces, hyphens, etc."
-- fields:
- - device.model_number
- - device.catalog_number
- - device.lot_number
- - device.other_id_number
-- "**Age and expiration date**"
-- fields:
- - device.expiration_date_of_device
- - device.device_age_text
-- "**Evaluation by manufacturer**"
-- fields:
- - device.device_availability
- - device.date_returned_to_manufacturer
- - device.device_evaluated_by_manufacturer
-- "### Use of Device"
-- "The following fields describe who was operating the device, if applicable, and whether it was an implanted device."
-- fields:
- - device.device_operator
- - device.implant_flag
- - device.date_removed_flag
-- "### Manufacturer"
-- "Each device has its own fields for identification of the manufacturer."
-- "**Device manufacturer name**"
-- fields:
- - device.manufacturer_d_name
-- "**Address**"
-- fields:
- - device.manufacturer_d_address_1
- - device.manufacturer_d_address_2
- - device.manufacturer_d_city
- - device.manufacturer_d_state
- - device.manufacturer_d_zip_code
- - device.manufacturer_d_zip_code_ext
- - device.manufacturer_d_postal_code
- - device.manufacturer_d_country
-- "### Patient"
-- "If there were patients noted in the adverse event report, there will be patient section, consisting of a list of patient treatment and outcomes. Each object in the `patient` section consists of the following fields."
-- example: patient
-- fields:
- - patient.date_received
- - patient.patient_sequence_number
- - patient.sequence_number_outcome
- - patient.sequence_number_treatment
-- "### Report text"
-- "The `mdr_text` section contains narrative information about the adverse event or problem report. Text may be about the problem, about the device, or about the patient adverse event, depending on the nature of the report. Each narrative or text description has the following fields."
-- example: mdr_text
-- fields:
- - mdr_text.date_report
- - mdr_text.mdr_text_key
- - mdr_text.patient_sequence_number
- - mdr_text.text
- - mdr_text.text_type_code
-- "### Reporter-dependent fields"
-- "### By user facility/importer"
-- "For reports submitted by user facilities, importers, or distributors, the following information is available."
-- fields:
- - type_of_report
- - date_facility_aware
- - report_date
- - report_to_fda
- - date_report_to_fda
- - report_to_manufacturer
- - date_report_to_manufacturer
- - event_location
-- "### Name and address"
-- fields:
- - distributor_name
- - distributor_address_1
- - distributor_address_2
- - distributor_city
- - distributor_state
- - distributor_zip_code
- - distributor_zip_code_ext
-- "### Suspect device manufacturer"
-- "User facilities/importers (distributors) include the suspect device manufacturer name and address in their reports."
-- fields:
- - manufacturer_name
- - manufacturer_address_1
- - manufacturer_address_2
- - manufacturer_city
- - manufacturer_postal_code
- - manufacturer_state
- - manufacturer_zip_code
- - manufacturer_zip_code_ext
- - manufacturer_country
- - manufacturer_contact_address_1
- - manufacturer_contact_address_2
- - manufacturer_contact_area_code
- - manufacturer_contact_city
- - manufacturer_contact_country
- - manufacturer_contact_exchange
- - manufacturer_contact_extension
- - manufacturer_contact_t_name
- - manufacturer_contact_f_name
- - manufacturer_contact_l_name
- - manufacturer_contact_pcity
- - manufacturer_contact_pcountry
- - manufacturer_contact_phone_number
- - manufacturer_contact_plocal
- - manufacturer_contact_postal_code
- - manufacturer_contact_state
- - manufacturer_contact_zip_code
- - manufacturer_contact_zip_ext
- - manufacturer_g1_name
- - manufacturer_g1_city
- - manufacturer_g1_country
- - manufacturer_g1_postal_code
- - manufacturer_g1_state
- - manufacturer_g1_address_1
- - manufacturer_g1_address_2
- - manufacturer_g1_zip_code
- - manufacturer_g1_zip_code_ext
-- "### By any manufacturer"
-- "This information is ordinarily provided by all manufacturers."
-- fields:
- - date_manufacturer_received
- - source_type
-- "### Keys and flags"
-- fields:
- - event_key
- - mdr_report_key
- - manufacturer_link_flag
-- "### OpenFDA fields"
-- fields:
- - device.openfda
-- "datasets"
diff --git a/pages/api_endpoints/device/event/_examples.json b/pages/api_endpoints/device/event/_examples.json
deleted file mode 100644
index e4089ca2..00000000
--- a/pages/api_endpoints/device/event/_examples.json
+++ /dev/null
@@ -1,149 +0,0 @@
-{
- "header": {
- "adverse_event_flag": "N",
- "date_manufacturer_received": "20120508",
- "date_of_event": "20120402",
- "date_received": "20120426",
- "date_report": "20120402",
- "device_date_of_manufacturer": "05/01/2011",
- "distributor_address_1": "",
- "distributor_address_2": "",
- "distributor_city": "",
- "distributor_name": "",
- "distributor_state": "",
- "distributor_zip_code": "",
- "distributor_zip_code_ext": "",
- "event_key": "",
- "event_location": "",
- "event_type": "Malfunction",
- "health_professional": "Y",
- "initial_report_to_fda": "No answer provided",
- "manufacturer_address_1": "ABBOTT VASCULAR",
- "manufacturer_address_2": "26531 YNEZ ROAD",
- "manufacturer_city": "TEMECULA",
- "manufacturer_contact_address_1": "ABBOTT VASCULAR",
- "manufacturer_contact_address_2": "26531 YNEZ ROAD",
- "manufacturer_contact_area_code": "951",
- "manufacturer_contact_city": "TEMECULA",
- "manufacturer_contact_country": "US",
- "manufacturer_contact_exchange": "951",
- "manufacturer_contact_extension": "",
- "manufacturer_contact_f_name": "CONNIE",
- "manufacturer_contact_l_name": "SPECK",
- "manufacturer_contact_pcity": "95191439",
- "manufacturer_contact_pcountry": "",
- "manufacturer_contact_phone_number": "9519",
- "manufacturer_contact_plocal": "9519143996",
- "manufacturer_contact_postal_code": "925914628",
- "manufacturer_contact_state": "CA",
- "manufacturer_contact_t_name": "",
- "manufacturer_contact_zip_code": "92591",
- "manufacturer_contact_zip_ext": "4628",
- "manufacturer_country": "US",
- "manufacturer_g1_address_1": "ABBOTT VASCULAR",
- "manufacturer_g1_address_2": "26531 YNEZ ROAD",
- "manufacturer_g1_city": "TEMECULA",
- "manufacturer_g1_country": "US",
- "manufacturer_g1_name": "CLONMEL, IRELAND REG# 9616693",
- "manufacturer_g1_postal_code": "92591 4628",
- "manufacturer_g1_state": "CA",
- "manufacturer_g1_zip_code": "92591",
- "manufacturer_g1_zip_code_ext": "462",
- "manufacturer_link_flag": "Y",
- "manufacturer_name": "AV-TEMECULA-CT",
- "manufacturer_postal_code": "92591 4628",
- "manufacturer_state": "CA",
- "manufacturer_zip_code": "92591",
- "manufacturer_zip_code_ext": "462",
- "mdr_report_key": "2549344",
- "number_devices_in_event": "",
- "number_patients_in_event": "",
- "previous_use_code": "I",
- "product_problem_flag": "Y",
- "remedial_action": [
- "Other"
- ],
- "removal_correction_number": "",
- "report_number": "2024168-2012-02668",
- "report_source_code": "Manufacturer report",
- "report_to_fda": "",
- "report_to_manufacturer": "",
- "reporter_occupation_code": "HEALTH PROFESSIONAL",
- "reprocessed_and_reused_flag": "N",
- "single_use_flag": "Y",
- "source_type": [
- "Foreign",
- "Health Professional",
- "Company representation"
- ],
- "type_of_report": [
- "Initial submission",
- "Followup"
- ]
- },
- "device": [
- {
- "brand_name": "XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM",
- "catalog_number": "1009541-28",
- "date_received": "20120426",
- "date_removed_flag": "",
- "date_returned_to_manufacturer": "20120502",
- "device_age_text": "DA",
- "device_availability": "Device was returned to manufacturer",
- "device_evaluated_by_manufacturer": "R",
- "device_event_key": "",
- "device_operator": "HEALTH PROFESSIONAL",
- "device_report_product_code": "NIQ",
- "device_sequence_number": " 1.0",
- "expiration_date_of_device": "20130516",
- "generic_name": "DRUG ELUTING CORONARY STENT SYSTEM",
- "implant_flag": "",
- "lot_number": "1050441",
- "manufacturer_d_address_1": "ABBOTT VASCULAR",
- "manufacturer_d_address_2": "26531 YNEZ ROAD",
- "manufacturer_d_city": "TEMECULA",
- "manufacturer_d_country": "US",
- "manufacturer_d_name": "AV-TEMECULA-CT",
- "manufacturer_d_postal_code": "92591 4628",
- "manufacturer_d_state": "CA",
- "manufacturer_d_zip_code": "92591",
- "manufacturer_d_zip_code_ext": "462",
- "model_number": "",
- "openfda": {
- "device_class": "3",
- "device_name": "Coronary Drug-Eluting Stent",
- "medical_specialty_description": "Unknown",
- "regulation_number": ""
- },
- "other_id_number": ""
- }
- ],
- "mdr_text": [
- {
- "mdr_text_key": "2690736",
- "patient_sequence_number": "1",
- "text": "IT WAS REPORTED THAT AFTER PRE-DILATATION, THE 3.0 X 28 MM XIENCE V WAS ADVANCED BUT COULD NOT CROSS THE MODERATELY CALCIFIED, MILDLY TORTUOUS, CONCENTRIC, DE NOVO, AND 90% STENOSED LESION. THE DEVICE WAS REMOVED WITH RESISTANCE AND THE DISTAL STENT STRUT WAS NOTED TO BE FLARED. A NON-ABBOTT DEVICE WAS ADVANCED AND RESISTANCE WAS FELT, BUT WAS ABLE TO CROSS THE LESION. THERE WERE NO PATIENT EFFECTS REPORTED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.",
- "text_type_code": "Description of Event or Problem"
- },
- {
- "mdr_text_key": "9964619",
- "patient_sequence_number": "1",
- "text": "(B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.",
- "text_type_code": "Additional Manufacturer Narrative"
- },
- {
- "mdr_text_key": "20967394",
- "patient_sequence_number": "1",
- "text": "(B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE STENT DAMAGE WAS CONFIRMED. THE FAILURE TO CROSS AND RESISTANCE DURING REMOVAL COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.",
- "text_type_code": "Additional Manufacturer Narrative"
- }
- ],
- "patient": [
- {
- "date_received": "20120426",
- "patient_sequence_number": "1",
- "sequence_number_outcome": [],
- "sequence_number_treatment": "GUIDE WIRE: SION"
- }
- ]
- }
\ No newline at end of file
diff --git a/pages/api_endpoints/device/event/_explorers.yaml b/pages/api_endpoints/device/event/_explorers.yaml
deleted file mode 100644
index 26eb65d8..00000000
--- a/pages/api_endpoints/device/event/_explorers.yaml
+++ /dev/null
@@ -1,27 +0,0 @@
-oneReport:
- title: One adverse event report
- description:
- - This query searches for all records in a certain date range, and asks for a single one. See the header fields reference for more about `date_received`. Brackets `[ ]` are used to specify a range for date, number, or string fields.
- - See the [header fields reference](/device/event/reference/) for more about date_received. Brackets `[ ]` are used to specify a range for date, number, or string fields.
- params:
- - search for all records with `date_received` between Jan 01, 2013 and Dec 31, 2014. limit to 1 record.
- - see the header fields reference for more about `date_received`. Brackets [ ] are used to specify a range for date, number, or string fields.
- query: 'https://api.fda.gov/device/event.json?search=date_received:[20130101+TO+20141231]&limit=1'
-genericName:
- title: One report involving an x-ray device
- description:
- - This query searches for records matching a certain search term, and asks for a single one.
- - See the [reference](/device/event/reference/) for more fields you can use to narrow searches for device adverse event reports.
- params:
- - search for all records with `device.generic_name` (generic device name) contains x-ray
- query: 'https://api.fda.gov/device/event.json?search=device.generic_name:x-ray&limit=1'
-topEvents:
- title: Count of top event types associated with x-ray devices
- description:
- - This query is similar to the prior one, but returns a count of the most frequently reported event types.
- - The suffix .exact is required by openFDA to count the unique full phrases in the field `event_type`. Without it, the API will count each word in that field individually—*No answer provided* would be counted as separate values, No and answer and provided.
- - See the [reference](/device/event/reference/) for more fields you can use to count and understand the nature of device adverse event reports.
- params:
- - search for all records with `device.generic_name` (generic device name) contains x-ray
- - count the field `event_type` (outcomes associated with an adverse event report)
- query: 'https://api.fda.gov/device/event.json?search=device.generic_name:x-ray&count=event_type.exact'
\ No newline at end of file
diff --git a/pages/api_endpoints/device/event/_fields.yaml b/pages/api_endpoints/device/event/_fields.yaml
deleted file mode 100644
index 018b0cfe..00000000
--- a/pages/api_endpoints/device/event/_fields.yaml
+++ /dev/null
@@ -1,1031 +0,0 @@
-properties:
- adverse_event_flag:
- description: "Whether the report is about an incident where the use of the device is suspected to have resulted in an adverse outcome in a patient."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Y': Yes
- 'N': No
- type: string
- date_facility_aware:
- description: "Date the user facility’s medical personnel or the importer (distributor) became aware that the device has or may have caused or contributed to the reported event."
- format: date
- is_exact: false
- possible_values:
- type: string
- date_manufacturer_received:
- description: "Date when the applicant, manufacturer, corporate affiliate, etc. receives information that an adverse event or medical device malfunction has occurred. This would apply to a report received anywhere in the world. For follow-up reports, the date that the follow-up information was received."
- format: date
- is_exact: false
- possible_values:
- type: string
- date_of_event:
- description: "Actual or best estimate of the date of first onset of the adverse event. This field was added in 2006."
- format: date
- is_exact: false
- possible_values:
- type: string
- date_received:
- description: "Date the report was received by the FDA."
- format: date
- is_exact: false
- possible_values:
- type: string
- date_report:
- description: "Date the initial reporter (whoever initially provided information to the user facility, manufacturer, or importer) provided the information about the event."
- format: date
- is_exact: false
- possible_values:
- type: string
- date_report_to_fda:
- description: "Date the user facility/importer (distributor) sent the report to the FDA, if applicable."
- format: date
- is_exact: false
- possible_values:
- type: string
- date_report_to_manufacturer:
- description: "Date the user facility/importer (distributor) sent the report to the manufacturer, if applicable."
- format: date
- is_exact: false
- possible_values:
- type: string
- device:
- items:
- properties:
- brand_name:
- description: "The trade or proprietary name of the suspect medical device as used in product labeling or in the catalog (e.g. Flo-Easy Catheter, Reliable Heart Pacemaker, etc.). If the suspect device is a reprocessed single-use device, this field will contain `NA`."
- format:
- is_exact: true
- possible_values:
- type: string
- catalog_number:
- description: "The exact number as it appears in the manufacturer’s catalog, device labeling, or accompanying packaging."
- format:
- is_exact: true
- possible_values:
- type: string
- date_received:
- description: "Documentation forthcoming. TK"
- format: date
- is_exact: false
- possible_values:
- type: string
- date_removed_flag:
- description: "Whether an implanted device was removed from the patient, and if so, what kind of date was provided."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Month and year provided only day defaults to 01': "Only a year and month were provided. Day was set to 01."
- 'Year provided only': "Only a year was provided. Month was set to 01 (January) and day set to 01."
- 'No information at this time': "Documentation forthcoming."
- 'Not available': "Documentation forthcoming."
- 'Unknown': "Documentation forthcoming."
- '*': "Documentation forthcoming."
- 'B': "Documentation forthcoming."
- 'V': "Documentation forthcoming."
- type: string
- date_returned_to_manufacturer:
- description: "Date the device was returned to the manufacturer, if applicable."
- format: date
- is_exact: false
- possible_values:
- type: string
- device_age_text:
- description: "Age of the device or a best estimate, often including the unit of time used. Contents vary widely, but common patterns include: ## Mo or ## Yr (meaning number of months or years, respectively."
- format:
- is_exact: true
- possible_values:
- type: string
- device_availability:
- description: "Whether the device is available for evaluation by the manufacturer, or whether the device was returned to the manufacturer."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Yes': "Yes"
- 'No': "No"
- 'Device was returned to manufacturer': "Device was returned to manufacturer"
- 'No answer provided': "No answer provided"
- 'I': "Documentation forthcoming."
- type: string
- device_evaluated_by_manufacturer:
- description: "Whether the suspect device was evaluated by the manufacturer."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Yes': "An evaluation was made of the suspect or related medical device."
- 'No': "An evaluation of a returned suspect or related medical device was not conducted."
- 'Device not returned to manufacturer': "An evaluation could not be made because the device was not returned to, or made available to, the manufacturer."
- 'No answer provided or empty': "No answer was provided or this information was unavailable."
- type: string
- device_event_key:
- description: "Documentation forthcoming."
- format:
- is_exact: true
- possible_values:
- type: string
- device_operator:
- description: "The person using the medical device at the time of the adverse event. This may be a health professional, a lay person, or may not be applicable."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Physician': "Physician"
- 'Nurse': "Nurse"
- 'Health professional': "Health professional"
- 'Lay user/patient': "Lay user/patient"
- 'Other health care professional': "Other health care professional"
- 'Audiologist': "Audiologist"
- 'Dental hygienist': "Dental hygienist"
- 'Dietician': "Dietician"
- 'Emergency medical technician': "Emergency medical technician"
- 'Medical technologist': "Medical technologist"
- 'Nuclear medicine technologist': "Nuclear medicine technologist"
- 'Occupational therapist': "Occupational therapist"
- 'Paramedic': "Paramedic"
- 'Pharmacist': "Pharmacist"
- 'Phlebotomist': "Phlebotomist"
- 'Physical therapist': "Physical therapist"
- 'Physician assistant': "Physician assistant"
- 'Radiologic technologist': "Radiologic technologist"
- 'Respiratory therapist': "Respiratory therapist"
- 'Speech therapist': "Speech therapist"
- 'Dentist': "Dentist"
- 'Other caregivers': "Other caregivers"
- 'Dental assistant': "Dental assistant"
- 'Home health aide': "Home health aide"
- 'Medical assistant': "Medical assistant"
- 'Nursing assistant': "Nursing assistant"
- 'Patient': "Patient"
- 'Patient family member or friend': "Patient family member or friend"
- 'Personal care assistant': "Personal care assistant"
- 'Service and testing personnel': "Service and testing personnel"
- 'Biomedical engineer': "Biomedical engineer"
- 'Hospital service technician': "Hospital service technician"
- 'Medical equipment company technician/representative': "Medical equipment company technician/representative"
- 'Physicist': "Physicist"
- 'Service personnel': "Service personnel"
- 'Device unattended': "Device unattended"
- 'Risk manager': "Risk manager"
- 'Attorney': "Attorney"
- 'Other': "Other"
- 'Unknown': "Unknown"
- 'Not applicable': "Not applicable"
- 'No information': "No information"
- 'Invalid data': "Invalid data"
- type: string
- device_report_product_code:
- description: "Three-letter FDA Product Classification Code. Medical devices are classified under 21 CFR Parts 862-892. "
- format:
- is_exact: true
- possible_values:
- type: reference
- value:
- name: "Product Classification Database"
- link: "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm"
- type: string
- device_sequence_number:
- description: "Number identifying this particular device. For example, the first device object will have the value 1. This is an enumeration corresponding to the number of patients involved in an adverse event."
- format:
- is_exact: true
- possible_values:
- type: string
- expiration_date_of_device:
- description: "If available; this date is often be found on the device itself or printed on the accompanying packaging."
- format: date
- is_exact: false
- possible_values:
- type: string
- generic_name:
- description: "The generic or common name of the suspect medical device or a generally descriptive name (e.g. urological catheter, heart pacemaker, patient restraint, etc.)."
- format:
- is_exact: true
- possible_values:
- type: string
- implant_flag:
- description: "Whether a device was implanted or not. May be either marked N or left empty if this was not applicable."
- format:
- is_exact: true
- possible_values:
- type: string
- lot_number:
- description: "If available, the lot number found on the label or packaging material."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_d_address_1:
- description: "Device manufacturer address line 1."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_d_address_2:
- description: "Device manufacturer address line 2."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_d_city:
- description: "Device manufacturer city."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_d_country:
- description: "Device manufacturer country."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_d_name:
- description: "Device manufacturer name."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_d_postal_code:
- description: "Device manufacturer postal code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_d_state:
- description: "Device manufacturer state code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_d_zip_code:
- description: "Device manufacturer zip code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_d_zip_code_ext:
- description: "Device manufacturer zip code extension."
- format:
- is_exact: true
- possible_values:
- type: string
- model_number:
- description: "The exact model number found on the device label or accompanying packaging."
- format:
- is_exact: true
- possible_values:
- type: string
- openfda:
- properties:
- device_class:
- description: "A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)"
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "Class I (low to moderate risk): general controls"
- '2': "Class II (moderate to high risk): general controls and special controls"
- '3': "Class III (high risk): general controls and Premarket Approval (PMA)"
- 'U': "Unclassified"
- 'N': "Not classified"
- 'F': "HDE"
- type: string
- device_name:
- description: "This is the proprietary name, or trade name, of the cleared device."
- format:
- is_exact: true
- possible_values:
- type: string
- fei_number:
- items:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- medical_specialty_description:
- description: "Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the “Regulation Medical Specialty” field."
- format:
- is_exact: true
- possible_values:
- type: string
- registration_number:
- items:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- regulation_number:
- items:
- description: "The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device."
- format:
- is_exact: true
- possible_values:
- type: reference
- value:
- name: "CFR database"
- link: "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm"
- type: string
- type: array
- type: object
- other_id_number:
- description: "Any other identifier that might be used to identify the device. Expect wide variability in the use of this field. It is commonly empty, or marked `NA`, `N/A`, `*`, or `UNK`, if unknown or not applicable."
- format:
- is_exact: true
- possible_values:
- type: string
- type: object
- type: array
- device_date_of_manufacturer:
- description: "Date of manufacture of the suspect medical device."
- format: date
- is_exact: false
- possible_values:
- type: string
- distributor_address_1:
- description: "User facility or importer (distributor) address line 1."
- format:
- is_exact: true
- possible_values:
- type: string
- distributor_address_2:
- description: "User facility or importer (distributor) address line 2."
- format:
- is_exact: true
- possible_values:
- type: string
- distributor_city:
- description: "User facility or importer (distributor) city."
- format:
- is_exact: true
- possible_values:
- type: string
- distributor_name:
- description: "User facility or importer (distributor) name."
- format:
- is_exact: true
- possible_values:
- type: string
- distributor_state:
- description: "User facility or importer (distributor) two-digit state code."
- format:
- is_exact: true
- possible_values:
- type: string
- distributor_zip_code:
- description: "User facility or importer (distributor) 5-digit zip code."
- format:
- is_exact: true
- possible_values:
- type: string
- distributor_zip_code_ext:
- description: "User facility or importer (distributor) 4-digit zip code extension (zip+4 code)."
- format:
- is_exact: true
- possible_values:
- type: string
- event_key:
- description: "Documentation forthcoming."
- format:
- is_exact: true
- possible_values:
- type: string
- event_location:
- description: "Where the event occurred."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Other': "Other"
- 'Hospital': "Hospital"
- 'Home': "Home"
- 'Nursing home': "Nursing home"
- 'Outpatient treatment facility': "Outpatient treatment facility"
- 'Outpatient diagnostic facility': "Outpatient diagnostic facility"
- 'Ambulatory surgical facility': "Ambulatory surgical facility"
- 'Catheterization suite': "Catheterization suite"
- 'Critical care unit': "Critical care unit"
- 'Dialysis unit': "Dialysis unit"
- 'Emergency room': "Emergency room"
- 'Examination room': "Examination room"
- 'Laboratory/pathology department': "Laboratory/pathology department"
- 'Maternity ward - nursery': "Maternity ward - nursery"
- 'Operating room': "Operating room"
- 'Outpatient clinic/surgery': "Outpatient clinic/surgery"
- 'Patients room or ward': "Patients room or ward"
- 'Radiology department': "Radiology department"
- 'Ambulatory health care facility': "Ambulatory health care facility"
- 'Ambulatory surgical center': "Ambulatory surgical center"
- 'Blood bank': "Blood bank"
- 'Bloodmobile': "Bloodmobile"
- 'Catheterization lab - free standing': "Catheterization lab - free standing"
- 'Chemotherapy center': "Chemotherapy center"
- 'Clinic - walk in, other': "Clinic - walk in, other"
- 'Dialysis center': "Dialysis center"
- 'Drug clinic': "Drug clinic"
- 'Imaging center - mobile': "Imaging center - mobile"
- 'Imaging center - stationary': "Imaging center - stationary"
- 'Laboratory': "Laboratory"
- 'Mobile health unit': "Mobile health unit"
- 'Mri centers': "Mri centers"
- 'Psychiatric center - walk in, other': "Psychiatric center - walk in, other"
- 'Tuberculosis clinic': "Tuberculosis clinic"
- 'Urgent care center': "Urgent care center"
- 'Long-term care facility': "Long-term care facility"
- 'Hospice': "Hospice"
- 'Psychiatric facility': "Psychiatric facility"
- 'Rehabilitation center': "Rehabilitation center"
- 'Retirement home': "Retirement home"
- 'Patients home': "Patients home"
- 'In transit to user/medical facility': "In transit to user/medical facility"
- 'Public venue': "Public venue"
- 'Outdoors': "Outdoors"
- 'Park': "Park"
- 'Playground': "Playground"
- 'Public building': "Public building"
- 'School': "School"
- 'Street': "Street"
- 'Unknown': "Unknown"
- 'Not applicable': "Not applicable"
- 'No information': "No information"
- 'Invalid data': "Invalid data"
- type: string
- event_type:
- description: "Outcomes associated with the adverse event."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Death': "Death, either caused by or associated with the adverse event."
- 'Injury (IN)': "Documentation forthcoming."
- 'Injury (IL)': "Documentation forthcoming."
- 'Injury (IJ)': "Documentation forthcoming."
- 'Malfunction': "Product malfunction."
- 'Other': "Other serious/important medical event."
- 'No answer provided': "No information was provided."
- type: string
- expiration_date_of_device:
- description: "If available; this date is often be found on the device itself or printed on the accompanying packaging."
- format: date
- is_exact: false
- possible_values:
- type: string
- health_professional:
- description: "Whether the initial reporter was a health professional (e.g. physician, pharmacist, nurse, etc.) or not."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Y': "The initial reporter is a health professional."
- 'N': "The initial reporter is not a health professional."
- type: string
- initial_report_to_fda:
- description: "Whether the initial reporter also notified or submitted a copy of this report to FDA."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Yes': "FDA was also notified by the initial reporter."
- 'No': "FDA was not notified by the initial reporter."
- 'Unknown': "Unknown whether FDA was also notified by the initial reporter."
- 'No answer provided or empty': "This information was not provided."
- type: string
- manufacturer_address_1:
- description: "Suspect medical device manufacturer address line 1."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_address_2:
- description: "Suspect medical device manufacturer address line 2."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_city:
- description: "Suspect medical device manufacturer city."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_address_1:
- description: "Suspect medical device manufacturer contact address line 1."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_address_2:
- description: "Suspect medical device manufacturer contact address line 2."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_area_code:
- description: "Manufacturer contact person phone number area code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_city:
- description: "Manufacturer contact person city."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_country:
- description: "Manufacturer contact person two-letter country code. Note: For medical device adverse event reports, comparing country codes with city names in the same record demonstrates widespread use of conflicting codes. Caution should be exercised when interpreting country code data in device records."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_exchange:
- description: "Manufacturer contact person phone number exchange."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_extension:
- description: "Manufacturer contact person phone number extension."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_f_name:
- description: "Manufacturer contact person first name."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_l_name:
- description: "Manufacturer contact person last name."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_pcity:
- description: "Manufacturer contact person phone number city code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_pcountry:
- description: "Manufacturer contact person phone number country code. Note: For medical device adverse event reports, comparing country codes with city names in the same record demonstrates widespread use of conflicting codes. Caution should be exercised when interpreting country code data in device records."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_phone_number:
- description: "Manufacturer contact person phone number."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_plocal:
- description: "Manufacturer contact person local phone number."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_postal_code:
- description: "Manufacturer contact person postal code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_state:
- description: "Manufacturer contact person two-letter state code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_t_name:
- description: "Manufacturer contact person title (Mr., Mrs., Ms., Dr., etc.)"
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_zip_code:
- description: "Manufacturer contact person 5-digit zip code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_contact_zip_ext:
- description: "Manufacturer contact person 4-digit zip code extension (zip+4 code)."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_country:
- description: "Suspect medical device manufacturer two-letter country code. Note: For medical device adverse event reports, comparing country codes with city names in the same record demonstrates widespread use of conflicting codes. Caution should be exercised when interpreting country code data in device records."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_g1_address_1:
- description: "Device manufacturer address line 1."
- format:
- is_exact: false
- possible_values:
- type: string
- manufacturer_g1_address_2:
- description: "Device manufacturer address line 2."
- format:
- is_exact: false
- possible_values:
- type: string
- manufacturer_g1_city:
- description: "Device manufacturer address city."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_g1_country:
- description: "Device manufacturer two-letter country code. Note: For medical device adverse event reports, comparing country codes with city names in the same record demonstrates widespread use of conflicting codes. Caution should be exercised when interpreting country code data in device records."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_g1_name:
- description: "Device manufacturer name."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_g1_postal_code:
- description: "Device manufacturer address postal code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_g1_state:
- description: "Device manufacturer address state."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_g1_zip_code:
- description: "Device manufacturer address zip code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_g1_zip_code_ext:
- description: "Device manufacturer address zip code extension."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_link_flag:
- description: "Indicates whether a user facility/importer-submitted (distributor-submitted) report has had subsequent manufacturer-submitted reports. If so, the distributor information (address, etc.) will also be present and this field will contain `Y`."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Y': "There are subsequent manufacturer-submitted reports."
- 'N': "There are no subsequent manufacturer-submitted reports."
- type: string
- manufacturer_name:
- description: "Suspect medical device manufacturer name."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_postal_code:
- description: "Suspect medical device manufacturer postal code. May contain the zip code for addresses in the United States."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_state:
- description: "Suspect medical device manufacturer two-letter state code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_zip_code:
- description: "Suspect medical device manufacturer 5-digit zip code."
- format:
- is_exact: true
- possible_values:
- type: string
- manufacturer_zip_code_ext:
- description: "Suspect medical device manufacturer 4-digit zip code extension (zip+4 code)."
- format:
- is_exact: true
- possible_values:
- type: string
- mdr_report_key:
- description: "A unique identifier for a report. This key is part of the download files and is used to join the four files together."
- format:
- is_exact: true
- possible_values:
- type: string
- mdr_text:
- items:
- properties:
- date_report:
- description: "Date the initial reporter (whoever initially provided information to the user facility, manufacturer, or importer) provided the information about the event."
- format: date
- is_exact: false
- possible_values:
- type: string
- mdr_text_key:
- description: "Documentation forthcoming."
- format:
- is_exact: true
- possible_values:
- type: string
- patient_sequence_number:
- description: "Number identifying this particular patient. For example, the first patient object will have the value 1. This is an enumeration corresponding to the number of patients involved in an adverse event."
- format:
- is_exact: true
- possible_values:
- type: string
- text:
- description: "Narrative text or problem description."
- format:
- is_exact: true
- possible_values:
- type: string
- text_type_code:
- description: "String that describes the type of narrative contained within the text field."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Description of Event or Problem': "The problem (quality, performance, or safety concern) in sufficient detail so that the circumstances surrounding the defect or malfunction of the medical product can be understood. For patient adverse events, may include a description of the event in detail using the reporter’s own words, including a description of what happened and a summary of all relevant clinical information (medical status prior to the event; signs and/or symptoms; differential diagnosis for the event in question; clinical course; treatment; outcome, etc.). If available and if relevant, may include synopses of any office visit notes or the hospital discharge summary. This section may also contain information about surgical procedures and laboratory tests."
- 'Manufacturer Evaluation Summary': "If available, the results of any evaluation of a malfunctioning device and, if known, any relevant maintenance/service information should be included in this section."
- 'Additional Manufacturer Narrative': "Documentation forthcoming."
- type: string
- type: object
- type: array
- number_devices_in_event:
- description: "Number of devices noted in the adverse event report. Almost always `1`. May be empty if `report_source_code` contains `Voluntary report`."
- format:
- is_exact: true
- possible_values:
- type: string
- number_patients_in_event:
- description: "Number of patients noted in the adverse event report. Almost always `1`. May be empty if `report_source_code` contains `Voluntary report`."
- format:
- is_exact: true
- possible_values:
- type: string
- patient:
- items:
- properties:
- date_received:
- description: "Date the report about this patient was received."
- format: date
- is_exact: false
- possible_values:
- type: string
- patient_sequence_number:
- description: "Documentation forthcoming."
- format:
- is_exact: true
- possible_values:
- type: string
- sequence_number_outcome:
- description: "Outcome associated with the adverse event for this patient. Expect wide variability in this field; each string in the list of strings may contain multiple outcomes, separated by commas, and with numbers, which may or may not be related to the `patient_sequence_number`."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Life Threatening': "Life Threatening"
- 'Hospitalization': "Hospitalization"
- 'Disability': "Disability"
- 'Congenital Anomaly': "Congenital Anomaly"
- 'Required Intervention': "Required Intervention"
- 'Other': "Other"
- 'Invalid Data': "Invalid Data"
- 'Unknown': "Unknown"
- 'No Information': "No Information"
- 'Not Applicable': "Not Applicable"
- 'Death': "Death"
- type: string
- sequence_number_treatment:
- description: "Treatment the patient received."
- format:
- is_exact: true
- possible_values:
- type: string
- type: object
- type: array
- previous_use_code:
- description: "Whether the use of the suspect medical device was the initial use, reuse, or unknown."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'I': "Initial use."
- 'R': "Reuse."
- 'U': "Unknown."
- '*': "Invalid data or this information was not provided."
- type: string
- product_problem_flag:
- description: "Indicates whether or not a report was about the quality, performance or safety of a device."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Y': "The report is about the quality, performance, or safety of a device—for example, defects or malfunctions. This flag is set when a device malfunction could lead to a death or serious injury if the malfunction were to recur."
- 'N': "The report is not about a defect or malfunction."
- type: string
- remedial_action:
- description: "Follow-up actions taken by the device manufacturer at the time of the report submission, if applicable."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Recall': "Recall"
- 'Repair': "Repair"
- 'Replace': "Replace"
- 'Relabeling': "Relabeling"
- 'Other': "Other"
- 'Notification': "Notification"
- 'Inspection': "Inspection"
- 'Patient Monitoring': "Patient Monitoring"
- 'Modification/Adjustment': "Modification/Adjustment"
- 'Invalid Data': "Invalid Data"
- type: string
- removal_correction_number:
- description: "If a corrective action was reported to FDA under 21 USC 360i(f), the correction or removal reporting number (according to the format directed by 21 CFR 807). If a firm has not submitted a correction or removal report to the FDA, but the FDA has assigned a recall number to the corrective action, the recall number may be used."
- format:
- is_exact: true
- possible_values:
- type: string
- report_date:
- description: "Date of the report, or the date that the report was forwarded to the manufacturer and/or the FDA."
- format: date
- is_exact: false
- possible_values:
- type: string
- report_number:
- description: "Identifying number for the adverse event report. The format varies, according to the source of the report. The field is empty when a user facility submits a report. *For manufacturer reports*. Manufacturer Report Number. The report number consists of three components: The manufacturer’s FDA registration number for the manufacturing site of the reported device, the 4-digit calendar year, and a consecutive 5-digit number for each report filed during the year by the manufacturer (e.g. 1234567-2013-00001, 1234567-2013-00002). *For user facility/importer (distributor) reports*. Distributor Report Number. Documentation forthcoming. *For consumer reports*. This field is empty."
- format:
- is_exact: true
- possible_values:
- type: string
- report_source_code:
- description: "Source of the adverse event report"
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Manufacturer report': "Manufacturer report"
- 'Voluntary report': "Voluntary report"
- 'User facility report': "User facility report"
- 'Distributor report': "Distributor report"
- type: string
- report_to_fda:
- description: "Whether the report was sent to the FDA by a user facility or importer (distributor). User facilities are required to send reports of device-related deaths. Importers are required to send reports of device-related deaths and serious injuries."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Y': "The report was sent to the FDA by a user facility or importer."
- 'N': "The report was not sent to the FDA by a user facility or importer."
- type: string
- report_to_manufacturer:
- description: "Whether the report was sent to the manufacturer by a user facility or importer (distributor). User facilities are required to send reports of device-related deaths and serious injuries to manufacturers. Importers are required to send reports to manufacturers of device-related deaths, device-related serious injuries, and device-related malfunctions that could cause or contribute to a death or serious injury."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Y': "The report was sent to the manufacturer by a user facility or importer."
- 'N': "The report was not sent to the manufacturer by a user facility or importer."
- type: string
- reporter_occupation_code:
- description: "Initial reporter occupation."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Physician': "Physician"
- 'Nurse': "Nurse"
- 'Health professional': "Health professional"
- 'Lay user/patient': "Lay user/patient"
- 'Other health care professional': "Other health care professional"
- 'Audiologist': "Audiologist"
- 'Dental hygienist': "Dental hygienist"
- 'Dietician': "Dietician"
- 'Emergency medical technician': "Emergency medical technician"
- 'Medical technologist': "Medical technologist"
- 'Nuclear medicine technologist': "Nuclear medicine technologist"
- 'Occupational therapist': "Occupational therapist"
- 'Paramedic': "Paramedic"
- 'Pharmacist': "Pharmacist"
- 'Phlebotomist': "Phlebotomist"
- 'Physical therapist': "Physical therapist"
- 'Physician assistant': "Physician assistant"
- 'Radiologic technologist': "Radiologic technologist"
- 'Respiratory therapist': "Respiratory therapist"
- 'Speech therapist': "Speech therapist"
- 'Dentist': "Dentist"
- 'Other caregivers': "Other caregivers"
- 'Dental assistant': "Dental assistant"
- 'Home health aide': "Home health aide"
- 'Medical assistant': "Medical assistant"
- 'Nursing assistant': "Nursing assistant"
- 'Patient': "Patient"
- 'Patient family member or friend': "Patient family member or friend"
- 'Personal care assistant': "Personal care assistant"
- 'Service and testing personnel': "Service and testing personnel"
- 'Biomedical engineer': "Biomedical engineer"
- 'Hospital service technician': "Hospital service technician"
- 'Medical equipment company technician/representative': "Medical equipment company technician/representative"
- 'Physicist': "Physicist"
- 'Service personnel': "Service personnel"
- 'Device unattended': "Device unattended"
- 'Risk manager': "Risk manager"
- 'Attorney': "Attorney"
- 'Other': "Other"
- 'Unknown': "Unknown"
- 'Not applicable': "Not applicable"
- 'No information': "No information"
- 'Invalid data': "Invalid data"
- type: string
- reprocessed_and_reused_flag:
- description: "Indicates whether the suspect device was a single-use device that was reprocessed and reused on a patient."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Y': "Was a single-use device that was reprocessed and reused."
- 'N': "Was not a single-use device that was reprocessed and reused."
- 'UNK': "The original equipment manufacturer was unable to determine if their single-use device was reprocessed and reused."
- type: string
- single_use_flag:
- description: "Whether the device was labeled for single use or not."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Yes': "The device was labeled for single use."
- 'No': "The device was not labeled for single use, or this is irrelevant to the device being reported (e.g. an X-ray machine)."
- type: string
- source_type:
- items:
- description: "The manufacturer-reported source of the adverse event report."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Other': "Other"
- 'Foreign': "Foreign"
- 'Study': "Study"
- 'Literature': "Literature"
- 'Consumer': "Consumer"
- 'Health Professional': "Health Professional"
- 'User facility': "User facility"
- 'Company representation': "Company representation"
- 'Distributor': "Distributor"
- 'Unknown': "Unknown"
- 'Invalid data': "Invalid data"
- type: string
- type: array
- type_of_report:
- items:
- description: "The type of report."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Initial submission': "Initial report of an event."
- 'Followup': "Additional or corrected information."
- 'Extra copy received': "Documentation forthcoming."
- 'Other information submitted': "Documentation forthcoming."
- type: string
- type: array
-type: object
\ No newline at end of file
diff --git a/pages/api_endpoints/device/event/_infographics.yaml b/pages/api_endpoints/device/event/_infographics.yaml
deleted file mode 100644
index 67274d5c..00000000
--- a/pages/api_endpoints/device/event/_infographics.yaml
+++ /dev/null
@@ -1,53 +0,0 @@
-- title: "Device adverse event reports over time"
- short: "Reports over time"
- description:
- - "This is the openFDA API endpoint for medical device adverse event reports. An adverse event report is submitted to the FDA to report serious injuries, deaths, malfunctions, and other undesirable effects associated with the use of medical devices. Increases in the number of reports may be due to greater use of medical devices, more awareness of reporting, news, enforcement actions, and other phenomena."
- countParam: "date_received"
- filters:
- - title: "Reports since 1991"
- searchParam: ""
- - title: "Reported by consumers"
- searchParam: "source_type:consumer"
- - title: "Reported device's generic name includes x-ray"
- searchParam: "device.generic_name:x-ray"
- - title: "Report originated in medical literature"
- searchParam: "source_type:literature"
- filterByDate: true
- type: Line
-- title: "What device types are reported?"
- short: "Devices"
- description:
- - "There are many ways to name and describe a medical device. In adverse event reports, devices are described using a generic name and also coded according to FDA [regulations](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051668.htm)."
- - "As you might expect, the nature of the medical device involved in an adverse event report varies with context such as the location or seriousness of the report. The chart below shows frequently reported device types, using their reported generic name."
- countParam: "device.generic_name.exact"
- filters:
- - title: "All adverse event reports"
- searchParam: ""
- - title: "Reported location of event is patient's home"
- searchParam: "event_location.exact:HOME+event_location:patient"
- - title: "Reported location of event is hospital"
- searchParam: "event_location:hospital"
- - title: "Reported event type is injury"
- searchParam: "event_type:injury"
- - title: "Reported event type is death"
- searchParam: "event_type:death"
- filterByDate: true
- type: Bar
-- title: "What adverse events are frequently reported?"
- short: "Types of events"
- description:
- - "Most adverse event reports describe medical device malfunctions and defects, and many report serious injuries or deaths. Exploring the context of device use and type of device reveals patterns in the seriousness of the reported events."
- countParam: "event_type.exact"
- filters:
- - title: "All adverse event reports"
- searchParam: ""
- - title: "Reported location of event is hospital"
- searchParam: "event_location:hospital"
- - title: "Generic name includes hospital bed"
- searchParam: device.generic_name:"hospital+bed"
- - title: "Generic name includes hip replacement"
- searchParam: device.generic_name:"hip+replacement"
- - title: "Generic name includes replacement heart valve"
- searchParam: device.generic_name:"replacement+heart+valve"
- filterByDate: true
- type: Bar
diff --git a/pages/api_endpoints/device/event/_meta.yaml b/pages/api_endpoints/device/event/_meta.yaml
deleted file mode 100644
index cb811948..00000000
--- a/pages/api_endpoints/device/event/_meta.yaml
+++ /dev/null
@@ -1,12 +0,0 @@
-type: endpoint
-documentTitle: openFDA › Device › Adverse events API
-label: Device adverse events
-title: Device Adverse Events
-description: An adverse event is submitted to the FDA to report any undesirable experience associated with the use of a device, including serious device side effects, product use errors, product quality problems, and therapeutic failures.
-datasets:
- - MAUDE
-path: /api_endpoints/device/event
-api_path: /device/event
-start: 19910101
-status: deviceevent
-dateConstraintKey: date_received
diff --git a/pages/api_endpoints/device/event/index.jsx b/pages/api_endpoints/device/event/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/device/event/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/device/index.jsx b/pages/api_endpoints/device/index.jsx
deleted file mode 100644
index bf4812b5..00000000
--- a/pages/api_endpoints/device/index.jsx
+++ /dev/null
@@ -1,53 +0,0 @@
-import React from 'react'
-import Layout from '../../../components/Layout'
-import Hero from '../../../components/Hero'
-import EndpointBox from '../../../components/EndpointBox'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-
-
-
Medical Device API Endpoints
-
-
-
-
-
-
-
-
-
-
-
-
-)
diff --git a/pages/api_endpoints/device/pma/_content.yaml b/pages/api_endpoints/device/pma/_content.yaml
deleted file mode 100644
index 7d7141bf..00000000
--- a/pages/api_endpoints/device/pma/_content.yaml
+++ /dev/null
@@ -1,47 +0,0 @@
-- "## About device pre-market approval"
-- "The PMA dataset contains details about specific products and the sponsors of premarket approval applications and supplements. It also contains administrative and tracking information about the applications and receipt and decision dates. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. An approved PMA Application is, in effect, a private license granted to the applicant for marketing a particular medical device."
-- "Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/device/pma.json` using search parameters for fields specific to the device PMA endpoint."
-- queryExplorer: oneAPPR
-- queryExplorer: oneLWP
-- queryExplorer: topAdvisory
-- "## Data reference"
-- "[General information about PMA](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm) that contains seemly everything that needs to be known about PMA."
-- "`PMA` is any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference. “PMA” includes a new drug application for a device under section 520(l) of the FD&C Act."
-- "### Downloads"
-- "downloads"
-- "## How records are organized"
-- example: header
-- example: openfda
-- "## Results"
-- "For non-`count` queries, the `results` section includes matching device registrations and listings records returned by the API."
-- "## Field-by-field reference"
-- fields:
- - advisory_committee
- - advisory_committee_description
- - ao_statement
- - generic_name
- - supplement_number
- - supplement_reason
- - supplement_type
- - trade_name
- - decision_date
- - fed_reg_notice_date
- - date_received
- - decision_code
- - product_code
- - pma_number
- - docket_number
- - expedited_review_flag
- - applicant
- - street_1
- - street_2
- - city
- - state
- - zip
- - zip_ext
-- "### OpenFDA"
-- "The `openfda` section of each document is determined initially by looking at the product_code value."
-- fields:
- - openfda
diff --git a/pages/api_endpoints/device/pma/_examples.json b/pages/api_endpoints/device/pma/_examples.json
deleted file mode 100644
index 701cf079..00000000
--- a/pages/api_endpoints/device/pma/_examples.json
+++ /dev/null
@@ -1,54 +0,0 @@
-{
- "header": {
- "advisory_committee": "EN",
- "advisory_committee_description": "Ear, Nose, Throat",
- "ao_statement": "APPROVAL FOR A CHANGE IN THE ALLOWABLE TOLERANCES OF THE SILICONE OVERMOLD IN THE DISTAL PORTION OF THE RECEIVING COIL FOR THE CI500 SERIES COCHLEAR IMPLANTS.",
- "applicant": "Cochlear Americas",
- "city": "Centennial",
- "date_received": "2009-10-05",
- "decision_code": "APPR",
- "decision_date": "2010-02-17",
- "docket_number": "",
- "expedited_review_flag": "N",
- "generic_name": "IMPLANT, COCHLEAR",
- "pma_number": "P970051",
- "product_code": "MCM",
- "state": "CO",
- "street_1": "13059 EAST PEAKVIEW AVENUE",
- "street_2": "",
- "supplement_number": "S054",
- "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
- "supplement_type": "135 Review Track For 30-Day Notice",
- "trade_name": "NUCLEUS 24 COCHLEAR IMPLANT SYSTEM",
- "zip": "80111",
- "zip_ext": ""
- },
- "openfda": {
- "device_class": "3",
- "device_name": "Implant, Cochlear",
- "fei_number": [
- "3006556115",
- "1721676",
- "3003045432",
- "3009092818",
- "3000249315",
- "3009762645",
- "3010223691",
- "3005900820",
- "3002806740"
- ],
- "medical_specialty_description": "Unknown",
- "registration_number": [
- "3006556115",
- "1721676",
- "9613646",
- "9710014",
- "3009092818",
- "3009762645",
- "3010223691",
- "3005900820",
- "3002806740"
- ],
- "regulation_number": ""
- }
-}
\ No newline at end of file
diff --git a/pages/api_endpoints/device/pma/_explorers.yaml b/pages/api_endpoints/device/pma/_explorers.yaml
deleted file mode 100644
index 26d08374..00000000
--- a/pages/api_endpoints/device/pma/_explorers.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-oneAPPR:
- title: One PMA record with the decision_code equal to APPR
- description:
- - This query searches for all records with a particular `decision_code`.
- params:
- - search for all records with `decision_code` equal to `APPR`.
- - limit to 1 record.
- query: 'https://api.fda.gov/device/pma.json?search=decision_code:APPR&limit=1'
-oneLWP:
- title: One PMA record for the LWP product code
- description:
- - This query searches for records matching a certain search term, and asks for a single one.
- - See the [reference](/device/pma/reference/) for more fields you can use to count and understand the nature of device PMA approval.
- params:
- - search for all records with `product_code` equals `LWP`.
- - limit to 1 record.
- query: 'https://api.fda.gov/device/pma.json?search=product_code:LWP&limit=1'
-topAdvisory:
- title: Count of top advisory committees for PMA submissions.
- description:
- - This query is similar to the prior one, but returns a count of the most frequent advisory committees.
- - See the [reference](/device/pma/reference/) for more fields you can use to count and understand the nature of device PMA approval.
- params:
- - search for all records.
- - count the field `advisory_committee`
- query: 'https://api.fda.gov/device/pma.json?count=advisory_committee'
\ No newline at end of file
diff --git a/pages/api_endpoints/device/pma/_fields.yaml b/pages/api_endpoints/device/pma/_fields.yaml
deleted file mode 100644
index 598f6326..00000000
--- a/pages/api_endpoints/device/pma/_fields.yaml
+++ /dev/null
@@ -1,242 +0,0 @@
-properties:
- advisory_committee:
- description: "This equates to the review division within CDRH in which the PMA would be reviewed, if it were reviewed today; this is derived from the procode and is always same as the “Review Panel” field in the Device Classification database (e.g. GU)."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'AN': "Anesthesiology"
- 'CV': "Cardiovascular"
- 'CH': "Clinical Chemistry"
- 'DE': "Dental"
- 'EN': "Ear, Nose, Throat"
- 'GU': "Gastroenterology, Urology"
- 'HO': "General Hospital"
- 'HE': "Hematology"
- 'IM': "Immunology"
- 'MI': "Microbiology"
- 'NE': "Neurology"
- 'OB': "Obstetrics/Gynecology"
- 'OP': "Ophthalmic"
- 'OR': "Orthopedic"
- 'PA': "Pathology"
- 'PM': "Physical Medicine"
- 'RA': "Radiology"
- 'SU': "General, Plastic Surgery"
- 'TX': "Clinical Toxicology"
- type: string
- advisory_committee_description:
- description: "Full spelling of the Advisory committee abbreviation (e.g. gastroenterology)."
- format:
- is_exact: true
- possible_values:
- type: string
- ao_statement:
- description: "Approval order statement: a brief description of the reason for the supplement/application approval by FDA."
- format:
- is_exact: false
- possible_values:
- type: string
- applicant:
- description: "The manufacturer of record or third party who submits a PMA submission for clearance (also known as sponsor)."
- format:
- is_exact: true
- possible_values:
- type: string
- city:
- description: "City of record of the applicant."
- format:
- is_exact: true
- possible_values:
- type: string
- date_received:
- description: "Date that the FDA Document Control Center received the submission."
- format: date
- is_exact: false
- possible_values:
- type: string
- decision_code:
- description: "A four digit code reflecting the final decision for a PMA submission."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'APPR': "Approval: PMA has been approved."
- 'WTDR': "Withdrawal: PMA has been withdrawn."
- 'DENY': "Denial: PMA has been denied."
- 'LE30': "30 day notice acceptance (decision made in ≤30 days)."
- 'APRL': "Reclassification after approval."
- 'APWD': "Withdrawal after approval."
- 'GT30': "No decision made in 30 days."
- 'APCV': "Conversion after approval. "
- type: string
- decision_date:
- description: "This is the date that FDA rendered a decision on the status of a PMA submission (i.e. clearance)."
- format: date
- is_exact: false
- possible_values:
- type: string
- docket_number:
- description: "The assigned posted docket number in the Federal Register."
- format:
- is_exact: false
- possible_values:
- type: string
- expedited_review_flag:
- description: "Flag indicating that the approval review process was expidited."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Y': "Yes"
- 'N': "No"
- type: string
- fed_reg_notice_date:
- description: "Documentation forthcoming."
- format: date
- is_exact: false
- possible_values:
- type: string
- generic_name:
- description: "Common or generic name as specified in the submission. Not to be confused with the official device nomenclature name related to the product code."
- format:
- is_exact: true
- possible_values:
- type: string
- openfda:
- properties:
- device_class:
- description: "A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)"
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "Class I (low to moderate risk): general controls"
- '2': "Class II (moderate to high risk): general controls and special controls"
- '3': "Class III (high risk): general controls and Premarket Approval (PMA)"
- 'U': "Unclassified"
- 'N': "Not classified"
- 'F': "HDE"
- type: string
- device_name:
- description: "This is the proprietary name, or trade name, of the cleared device."
- format:
- is_exact: true
- possible_values:
- type: string
- fei_number:
- items:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- medical_specialty_description:
- description: "Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the “Regulation Medical Specialty” field."
- format:
- is_exact: true
- possible_values:
- type: string
- registration_number:
- items:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- regulation_number:
- items:
- description: "The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device."
- format:
- is_exact: true
- possible_values:
- type: reference
- value:
- name: "CFR database"
- link: "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm"
- type: string
- type: array
- type: object
- pma_number:
- description: "FDA-assigned premarket application number, including leading letters. Leading letter “D” indicates Product Development Protocol type of Premarket Approval. Leading letters “BP” indicates Premarket Approval by Center for Biologics Evaluation and Research. Leading letter “H” indicates Humanitarian Device Exemption approval. Leading letter “N” indicates New Drug Application. Early PMAs were approved as NDAs. Leading letter “P” indicates Premarket Approval."
- format:
- is_exact: false
- possible_values:
- type: string
- product_code:
- description: "A three-letter identifier assigned to a device category. Assignment is based upon the medical device classification designated under 21 CFR Parts 862-892, and the technology and intended use of the device. Occasionally these codes are changed over time."
- format:
- is_exact: false
- possible_values:
- type: string
- state:
- description: "Portion of address that designates the state of the applicant."
- format:
- is_exact: false
- possible_values:
- type: string
- street_1:
- description: "Delivery address of the applicant."
- format:
- is_exact: false
- possible_values:
- type: string
- street_2:
- description: "Delivery address of the applicant."
- format:
- is_exact: false
- possible_values:
- type: string
- supplement_number:
- description: "FDA assigned supplement number."
- format:
- is_exact: false
- possible_values:
- type: string
- supplement_reason:
- description: "General description for the reason for the supplement or application."
- format:
- is_exact: false
- possible_values:
- type: string
- supplement_type:
- description: "[Link to general criteria used for PMA regulation](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814). The “PMA regulation” (21 CFR Part 814) sets forth general criteria for determining when you must submit a PMA supplement or a 30-day notice for a device modification or manufacturing change (21 CFR 814.39). See [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050467.htm#types) for more detail."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Subpart B': "“Premarket Approval Application” of the PMA regulation in Part 814 describes PMA amendments and supplements."
- 'Subpart E': "“Post Approval Requirements” describes requirements for continuing evaluation (post-approval studies), periodic reporting, and other requirements related to the continued reasonable assurance of safety and effectiveness of an approved PMA device. The Act defines different types of PMA supplements that are used to request approval of a change to a device that has an approved PMA (see section 737(4) of the Act (21 U.S.C. 379i(4)) for definitions of 180-day supplements, real-time supplements, panel-track supplements)."
- 'PMA supplement (180 days)': "Per section 737(4)(C) of the Act (21 U.S.C. 379i(4)(C)), this is a supplement to an approved premarket application or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling."
- 'Special PMA Supplement': "Changes Being Effected Sections 21 CFR 814.39(d)(1) and (d)(2)provide that certain labeling and manufacturing changes that enhance the safety of the device or the safety in the use of the device may be submitted as a supplement marked “Special PMA Supplement – Changes Being Effected.” The Special PMA Supplement is a narrow exception to the general rule that prior FDA approval of changes to a PMA, including the labeling for a device, is a condition of lawful distribution and, therefore, may only be utilized when (1) the applicant has newly acquired safety-related information; (2) the information in question was not previously submitted to the FDA; and (3) the information involves labeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction for which there is reasonable evidence of a causal association."
- '30-day Notice and 135 PMA Supplement': "Section 515(d) of the Act (21 U.S.C. 360e), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA)(Pub. L. 105-115), permits a PMA applicant to submit written notification to the agency of a modification to the manufacturing procedure or method of manufacture affecting the safety and effectiveness of the device rather than submitting such change as a PMA supplement. The applicant may distribute the device 30 days after the date on which FDA receives the notice, unless FDA finds such information in the 30-day notice is not adequate, notifies the applicant that the submission has been converted to a 135-day supplement (21 CFR 814.39(f)), and describes further information or action that is required for acceptance of the modification."
- 'PMA Manufacturing Site Change Supplement': "After approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change that affects the safety or effectiveness of the device, including a change that uses a different facility or establishment to manufacture, process, or package the device. Such a PMA supplement for a move to a different facility or establishment is called a “manufacturing site change supplement.”"
- 'Annual (periodic) Report or 30-day Supplements': "In accordance with 21 CFR 814.82(a)(7), FDA may require as a condition of approval submission to FDA at intervals specified in the approval order of periodic reports containing the information required by 21 CFR 814.84(b). In most cases, after the PMA is approved, the PMA applicant is required to submit reports to FDA annually unless a different time frame is specified in the approval order."
- 'PMA': "Any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference."
- type: string
- trade_name:
- description: "This is the proprietary name of the approved device."
- format:
- is_exact: true
- possible_values:
- type: string
- zip:
- description: "Portion of address that designates the zip code of the applicant."
- format:
- is_exact: false
- possible_values:
- type: string
- zip_ext:
- description: "Portion of address that designates the “speed zip” or the “+4” of the applicant."
- format:
- is_exact: false
- possible_values:
- type: string
-type: object
diff --git a/pages/api_endpoints/device/pma/_infographics.yaml b/pages/api_endpoints/device/pma/_infographics.yaml
deleted file mode 100644
index f103261d..00000000
--- a/pages/api_endpoints/device/pma/_infographics.yaml
+++ /dev/null
@@ -1,38 +0,0 @@
-- title: "Device PMA by advisory committee"
- short: "By advisory committee"
- description:
- - "The advisory committee equates to the review division within CDRH in which the PMA would be reviewed, if it were reviewed today; this is derived from the product code and is always same as the “Review Panel” field in the Device Classification database."
- countParam: "advisory_committee_description.exact"
- filters:
- - title: "All Device PMA by advisory committee"
- searchParam: ""
- - title: "Generic name contians implant"
- searchParam: "generic_name:IMPLANT"
- - title: "Decision code equals Approved"
- searchParam: "decision_code:APPR"
- - title: "Device class III"
- searchParam: "openfda.device_class:3"
- filterByDate: false
- type: Bar
-- title: "Device PMA approval by state"
- short: "By state"
- description:
- - "The state listed on the postal delivery address of the applicant."
- countParam: "state"
- filters:
- - title: "All PMA"
- searchParam: ""
- - title: "PMA with generic name containing implant"
- searchParam: "generic_name:IMPLANT"
- - title: "Advisory committee set to Anesthesiology"
- searchParam: "advisory_committee:AN"
- - title: "Device class equals 3"
- searchParam: "openfda.device_class:3"
- filterByDate: false
- type: Bar
-
-
-
-
-
-
diff --git a/pages/api_endpoints/device/pma/_meta.yaml b/pages/api_endpoints/device/pma/_meta.yaml
deleted file mode 100644
index 6b196d24..00000000
--- a/pages/api_endpoints/device/pma/_meta.yaml
+++ /dev/null
@@ -1,11 +0,0 @@
-type: endpoint
-documentTitle: openFDA › Device › PMA
-label: Device pre-market approval
-title: Device Pre-market Approval
-description: The PMA dataset contains details about specific products and the sponsors of premarket approval applications and supplements. It also contains administrative and tracking information about the applications and receipt and decision dates. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. An approved PMA Application is, in effect, a private license granted to the applicant for marketing a particular medical device.
-endpoint: device/pma
-datasets:
-path: /api_endpoints/device/pma
-api_path: /device/pma
-start:
-status: devicepma
\ No newline at end of file
diff --git a/pages/api_endpoints/device/pma/index.jsx b/pages/api_endpoints/device/pma/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/device/pma/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/device/recall/_content.yaml b/pages/api_endpoints/device/recall/_content.yaml
deleted file mode 100644
index c99f89e3..00000000
--- a/pages/api_endpoints/device/recall/_content.yaml
+++ /dev/null
@@ -1,42 +0,0 @@
-- "## About device recalls"
-- "A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. Recall as defined in 21 CFR 7.3(g) is “a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.” If a firm conducts a recall to reduce a risk to health, the firm is required to submit a written report to the FDA with the information described in 21 CFR 806.10."
-- "For additional information, see [here](http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm)."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/device/recall.json` using search parameters for fields specific to the device recalls endpoint."
-- queryExplorer: oneReport
-- queryExplorer: regulationNumber
-- queryExplorer: topProductCodes
-- "## Data reference"
-- "### Downloads"
-- "downloads"
-- "### How records are organized"
-- "Example:"
-- example: record
-- "## Anatomy of a response"
-- "This is a simulated openFDA API return for a non-`count` query. It is divided into two high-level sections, `meta` and `results`."
-- example: anatomy
-- "### Meta"
-- "For non-`count` queries, the `meta` section includes a disclaimer, a link to the openFDA data license, and information about the results that follow."
-- example: meta
-- fields:
- - meta.disclaimer
- - meta.license
- - meta.last_updated
- - meta.results.skip
- - meta.results.limit
- - meta.results.total
-- "### Results"
-- "For non-`count` queries, the `results` section includes matching adverse event reports returned by the API."
-- "## Field-by-field reference"
-- fields:
- - event_date_terminated
- - firm_fei_number
- - product_code
- - res_event_number
- - root_cause_description
- - k_numbers
- - pma_numbers
- - other_submission_description
-- "## OpenFDA"
-- fields:
- - openfda
diff --git a/pages/api_endpoints/device/recall/_examples.json b/pages/api_endpoints/device/recall/_examples.json
deleted file mode 100644
index 0c2a8ef3..00000000
--- a/pages/api_endpoints/device/recall/_examples.json
+++ /dev/null
@@ -1,57 +0,0 @@
-{
- "record": {
- "other_submission_description": "",
- "res_event_number": "52634",
- "firm_fei_number": "3002980729",
- "k_numbers": [
- "K082332"
- ],
- "openfda": {
- "device_name": "Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease",
- "registration_number": [
- "2031966"
- ],
- "fei_number": [
- "3002980729"
- ],
- "device_class": "3",
- "medical_specialty_description": "Orthopedic",
- "k_number": [
- "K082332"
- ],
- "regulation_number": "888.3070"
- },
- "product_code": "NKB",
- "root_cause_description": "Device Design",
- "pma_numbers": [],
- "event_date_terminated": "2012-11-19",
- "product_res_number": "Z-0359-2013"
- },
- "anatomy": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- },
- "results": [
- { }
- ]
- },
- "meta": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- }
- }
-}
diff --git a/pages/api_endpoints/device/recall/_explorers.yaml b/pages/api_endpoints/device/recall/_explorers.yaml
deleted file mode 100644
index dd776da8..00000000
--- a/pages/api_endpoints/device/recall/_explorers.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-oneReport:
- title: One adverse event report
- description:
- - This query searches for all records with a particular `product_code`.
- params:
- - "*search* for all records with `product_code` equal to `FOZ`."
- - "*limit* to 1 record"
- query: 'https://api.fda.gov/device/recall.json?search=product_code:FOZ&limit=1'
-regulationNumber:
- title: One recall for a *880.5200* regulation number
- description:
- - This query searches for records matching a certain search term, and asks for a single one.
- - See the [reference](/device/recall/reference/) for more fields you can use to narrow searches for device recall.
- params:
- - "*search* for all records with `openfda.regulation_number` equals *880.5200*"
- - "*limit* to 1 record"
- query: 'https://api.fda.gov/device/recall.json?search=openfda.regulation_number:880.5200&limit=1'
-topProductCodes:
- title: Count of top product codes for device recalls
- description:
- - This query is similar to the prior one, but returns a count of the most popular product codes.
- - See the [reference](/device/recall/reference/) for more fields you can use to narrow searches for device recall.
- params:
- - "*search* for all records."
- - count the field `product_code`
- query: 'https://api.fda.gov/device/recall.json?count=product_code'
diff --git a/pages/api_endpoints/device/recall/_fields.yaml b/pages/api_endpoints/device/recall/_fields.yaml
deleted file mode 100644
index 0a8f9804..00000000
--- a/pages/api_endpoints/device/recall/_fields.yaml
+++ /dev/null
@@ -1,169 +0,0 @@
-properties:
- event_date_terminated:
- description: "Date that FDA determined recall actions were completed and terminated the recall. For details about termination of a recall see [here](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=7.55)."
- format: date
- is_exact: false
- possible_values:
- type: string
- firm_fei_number:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- k_numbers:
- items:
- description: "FDA-assigned premarket notification number, including leading letters. Leading letters “BK” indicates 510(k) clearance, or Premarket Notification, cleared by Center for Biologics Evaluation and Research. Leading letters “DEN” indicates De Novo, or Evaluation of Automatic Class III Designation. Leading letter “K” indicates 510(k) clearance, or Premarket Notification. `Source`: 510(k)"
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- openfda:
- properties:
- device_class:
- description: "A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)"
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "Class I (low to moderate risk): general controls"
- '2': "Class II (moderate to high risk): general controls and special controls"
- '3': "Class III (high risk): general controls and Premarket Approval (PMA)"
- 'U': "Unclassified"
- 'N': "Not classified"
- 'F': "HDE"
- type: string
- device_name:
- description: "This is the proprietary name, or trade name, of the cleared device."
- format:
- is_exact: true
- possible_values:
- type: string
- fei_number:
- items:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- medical_specialty_description:
- description: "Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the “Regulation Medical Specialty” field."
- format:
- is_exact: true
- possible_values:
- type: string
- registration_number:
- items:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- regulation_number:
- items:
- description: "The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device."
- format:
- is_exact: true
- possible_values:
- type: reference
- value:
- name: "CFR database"
- link: "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm"
- type: string
- type: array
- type: object
- other_submission_description:
- description: "If 510(k) or PMA numbers are not applicable to the device recalled, the recall may contain other regulatory descriptions, such as `exempt`."
- format:
- is_exact: false
- possible_values:
- type: string
- pma_numbers:
- type: array
- items:
- description: "FDA-assigned premarket application number, including leading letters. Leading letter “D” indicates Product Development Protocol type of Premarket Approval. Leading letters “BP” indicates Premarket Approval by Center for Biologics Evaluation and Research. Leading letter “H” indicates Humanitarian Device Exemption approval. Leading letter “N” indicates New Drug Application. Early PMAs were approved as NDAs. Leading letter “P” indicates Premarket Approval."
- format:
- is_exact: true
- possible_values:
- type: string
- product_code:
- description: "A three-letter identifier assigned to a device category. Assignment is based upon the medical device classification designated under 21 CFR Parts 862-892, and the technology and intended use of the device. Occasionally these codes are changed over time."
- format:
- is_exact: false
- possible_values:
- type: string
- product_res_number:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- res_event_number:
- description: "A five digit, numerical designation assigned by FDA to a specific recall event used for tracking purposes."
- format:
- is_exact: false
- possible_values:
- type: string
- root_cause_description:
- description: "FDA determined general type of recall cause. Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall."
- format:
- is_exact: true
- possible_values:
- type: string
- meta:
- format:
- type: object
- description: 'This section contains a disclaimer and license information. The field `last_updated` indicates when the data files were exported.'
- possible_values:
- properties:
- type: object
- disclaimer:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Important details notes about openFDA data and limitations of the dataset."
- possible_values:
- license:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Link to a web page with license terms that govern data within openFDA."
- possible_values:
- last_updated:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "The last date when this openFDA endpoint was updated. Note that this does not correspond to the most recent record for the endpoint or dataset. Rather, it is the last time the openFDA API was itself updated."
- possible_values:
- results:
- type: object
- properties:
- skip:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Offset (page) of results, defined by the `skip` [query parameter](/api/)."
- possible_values:
- limit:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Number of records in this return, defined by the `limit` [query parameter](/api/). If there is no `limit` parameter, the API returns one result."
- possible_values:
- total:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Total number of records matching the search criteria."
- possible_values:
-type: object
diff --git a/pages/api_endpoints/device/recall/_infographics.yaml b/pages/api_endpoints/device/recall/_infographics.yaml
deleted file mode 100644
index 8d540046..00000000
--- a/pages/api_endpoints/device/recall/_infographics.yaml
+++ /dev/null
@@ -1,16 +0,0 @@
-- title: "Device recalls by product codes"
- short: "By product code"
- description:
- - "The name and product code identify the generic category of a device for FDA assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892."
- countParam: "product_code"
- filters:
- - title: "All recalls"
- searchParam: ""
- - title: "Root cause description *Device Design*"
- searchParam: "root_cause_description.exact:Device+Design"
- - title: "Device class equal to *III*"
- searchParam: "openfda.device_class:3"
- - title: "Regulation number *888.4540*"
- searchParam: "openfda.regulation_number:888.4540"
- filterByDate: true
- type: Line
\ No newline at end of file
diff --git a/pages/api_endpoints/device/recall/_meta.yaml b/pages/api_endpoints/device/recall/_meta.yaml
deleted file mode 100644
index 4a881aca..00000000
--- a/pages/api_endpoints/device/recall/_meta.yaml
+++ /dev/null
@@ -1,11 +0,0 @@
-type: endpoint
-documentTitle: openFDA › Device › Recalls API
-label: Device recalls
-title: Device Recalls
-description: A recall is an action taken to address a problem with a medical device that violates FDA law.
-datasets:
- - MAUDE
-path: /api_endpoints/device/recall
-api_path: /device/recall
-start: 20030101
-status: devicerecall
diff --git a/pages/api_endpoints/device/recall/index.jsx b/pages/api_endpoints/device/recall/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/device/recall/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/device/registrationlisting/_content.yaml b/pages/api_endpoints/device/registrationlisting/_content.yaml
deleted file mode 100644
index e5e7d866..00000000
--- a/pages/api_endpoints/device/registrationlisting/_content.yaml
+++ /dev/null
@@ -1,93 +0,0 @@
-- "## About device registrations and listings"
-- "The registration and listing dataset contains the location of medical device establishments and the devices manufactured at those establishments. Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment registration. Most foreign and domestic establishments that are required to register with the FDA are also required to list the devices that are made there for commercial distribution."
-- "For additional information, see [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm)."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/device/registrationlisting.json` using search parameters for fields specific to the device registrations and listings endpoint."
-- queryExplorer: oneReport
-- queryExplorer: regulationNumber
-- queryExplorer: topClasses
-- "## Data reference"
-- disclaimer:
- - "Registration and listing data are submitted and maintained by medical device companies that are required to identify their places of business and the devices they produce or process at those places of business. These data are generally not reviewed by FDA for accuracy or completeness and the appearance of these data on the FDA web site and on open.fda.gov does not infer FDA approval of either the products or the facilities.When using the Product data, keep in mind that the definition of 'product' can be variable, based on whether the device requires some form of premarket approval or notification, or can be marketed without any premarket review by FDA. You may want to identify the number of products by the number of proprietary names associated with a given data set rather than the number of product rows returned. However, as noted, the data provided by these APIs may or may not be complete as most of them have not been verified by FDA."
-- "### Downloads"
-- "downloads"
-- "## How records are organized"
-- example:
-- "## Results"
-- "For non-`count` queries, the `results` section includes matching device registrations and listings records returned by the API."
-- "## Field-by-field reference"
-- "### Registration"
-- "The Registration record provides identification (name, registration number) and address information for a medical device establishment that performs an activity that requires that they register with the FDA Center for Devices and Radiological Health (CDRH). [See](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm) for more information on who must register."
-- fields:
- - registration.status_code
- - registration.initial_importer_flag
- - registration.reg_expiry_date_year
- - registration.address_line_1
- - registration.address_line_2
- - registration.city
- - registration.state_code
- - registration.zip_code
- - registration.iso_country_code
- - registration.name
- - registration.postal_code
- - registration.fei_number
- - registration.registration_number
-- "### Owner operator"
-- "The Owner Operator is the company that owns or operates the registered establishment. They are responsible for the activities that are conducted at the registered establishment and the devices put in commercial distribution in the U.S. This is usually the corporate headquarters of the company."
-- "The Official Correspondent is the person who is responsible for maintaining the establishment’s registration and listing information with CDRH. This can be, but does not have be, the same person as the Owner Operator or, in the case of a foreign establishment, the US Agent."
-- fields:
- - registration.owner_operator.owner_operator_number
- - registration.owner_operator.firm_name
- - registration.owner_operator.official_correspondent.first_name
- - registration.owner_operator.official_correspondent.last_name
- - registration.owner_operator.official_correspondent.middle_initial
- - registration.owner_operator.official_correspondent.phone_number
- - registration.owner_operator.official_correspondent.subaccount_company_name
- - registration.owner_operator.contact_address.address_1
- - registration.owner_operator.contact_address.address_2
- - registration.owner_operator.contact_address.city
- - registration.owner_operator.contact_address.state_code
- - registration.owner_operator.contact_address.state_province
- - registration.owner_operator.contact_address.postal_code
- - registration.owner_operator.contact_address.iso_country_code
-- "### US Agent"
-- "The US agent is a person who must reside or keep a place of business in the United States and can represent the registered foreign establishment in communications with FDA. All foreign establishments are required to identify a single US agent for all of the products exported to the U.S. from their establishment."
-- fields:
- - registration.us_agent.name
- - registration.us_agent.business_name
- - registration.us_agent.address_line_1
- - registration.us_agent.address_line_2
- - registration.us_agent.city
- - registration.us_agent.state_code
- - registration.us_agent.zip_code
- - registration.us_agent.postal_code
- - registration.us_agent.iso_country_code
- - registration.us_agent.bus_phone_area_code
- - registration.us_agent.bus_phone_extn
- - registration.us_agent.bus_phone_num
- - registration.us_agent.fax_area_code
- - registration.us_agent.fax_num
- - registration.us_agent.email_address
-- "### Proprietary names"
-- "The Proprietary Names are the names under which the medical device is marketed in the U.S. The Proprietary Names are identified at the Owner Operator level, so they may not be accurately associated with individual establishments if a product is made at more than one establishment owned or operated by the same company. In other words, if a company makes a product under Proprietary Name “A” at Establishment “1” and under Proprietary Name “B” at Establishment “2,” it will appear in the Registration and Listing data as both products being made at both establishments."
-- fields:
- - proprietary_name
-- "### Establishment types"
-- "The Establishment Types identify the activity or activities being conducted at a given establishment for a given product. These include Manufacturer, Contract Manufacturer, Repacker/Relabeler, and several others. A company has to identify at least one Establishment Type for each product it makes. These are identified at the establishment and product listing level."
-- fields:
- - establishment_type
-- "### Products"
-- "All medical devices entering commerce in the U.S. must be “listed” with FDA. This means that each owner or operator of a medical device establishment that conducts an activity – manufactures, sterilizes, relabels, etc. – that is regulated by FDA must identify the devices that they market in the U.S. This can get a bit tricky as these products are identified differently depending on whether a company has to submit a premarket application or notification prior to marketing their device (see [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm))."
-- "If they do not have to submit a premarket application or notification, then the device is considered “exempt” from premarket notification, and the company identifies the device they are making by selecting the appropriate product code and providing the Establishment Types that apply to their establishment and the Proprietary Names they are marketing the device under. It will appear in the open.fda.gov data as one document or record."
-- "If, however, a company must get premarket approval or clearance, they identify the product they are making by the premarket approval (PMA, HDE, PDP or NDA) or clearance (510(k) or Denovo) number assigned by FDA. Each Establishment Type and Proprietary Name is then associated with the product in the open.fda.gov database based on that premarket number, not by product code, although all listings, including those that are not exempt, have product codes assigned."
-- fields:
- - k_number
- - pma_number
- - products.created_date
- - products.exempt
- - products.owner_operator_number
- - products.product_code
-- "### OpenFDA"
-- "The `openfda` section of each document is determined initially by looking at the product_code value. Since there are potentially more than one product_code values associated with a listing, there is an `openfda` subdocument for each one."
-- fields:
- - products.openfda
diff --git a/pages/api_endpoints/device/registrationlisting/_examples.json b/pages/api_endpoints/device/registrationlisting/_examples.json
deleted file mode 100644
index 4f58d903..00000000
--- a/pages/api_endpoints/device/registrationlisting/_examples.json
+++ /dev/null
@@ -1,70 +0,0 @@
-{
- "establishment_type": [
- "Manufacture Medical Device"
- ],
- "k_number": "",
- "pma_number": "P990041",
- "products": [
- {
- "created_date": "2007-12-18",
- "exempt": "",
- "openfda": {
- "device_class": "3",
- "device_name": "Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)",
- "medical_specialty_description": "Unknown",
- "regulation_number": ""
- },
- "owner_operator_number": "9051149",
- "product_code": "LOM"
- }
- ],
- "proprietary_name": [
- "ETI-AB-EBK PLUS"
- ],
- "registration": {
- "address_line_1": "VIA CRESCENTINO, snc",
- "address_line_2": "",
- "city": "SALUGGIA Vercelli",
- "fei_number": "3002808212",
- "initial_importer_flag": "N",
- "iso_country_code": "IT",
- "name": "DIASORIN S.P.A.",
- "owner_operator": {
- "contact_address": {
- "address_1": "Via Crescentino, snc",
- "address_2": "",
- "city": "Saluggia",
- "iso_country_code": "IT",
- "postal_code": "13040",
- "state_code": "IT-VC",
- "state_province": ""
- },
- "firm_name": "DiaSorin S.p.A",
- "official_correspondent": {},
- "owner_operator_number": "9051149"
- },
- "postal_code": "13040",
- "reg_expiry_date_year": "2016",
- "registration_number": "9610240",
- "state_code": "",
- "status_code": "1",
- "us_agent": {
- "address_line_1": "1951 NORTHWESTERN AVE.",
- "address_line_2": "",
- "bus_phone_area_code": "651",
- "bus_phone_extn": "",
- "bus_phone_num": "4399710",
- "business_name": "DIASORIN INC.",
- "city": "STILLWATER",
- "email_address": "john.walter@diasorin.com",
- "fax_area_code": "651",
- "fax_num": "3515669",
- "iso_country_code": "US",
- "name": "John C. Walter",
- "postal_code": "",
- "state_code": "MN",
- "zip_code": "55082"
- },
- "zip_code": ""
- }
-}
\ No newline at end of file
diff --git a/pages/api_endpoints/device/registrationlisting/_explorers.yaml b/pages/api_endpoints/device/registrationlisting/_explorers.yaml
deleted file mode 100644
index 9bf6fecb..00000000
--- a/pages/api_endpoints/device/registrationlisting/_explorers.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-oneReport:
- title: One device registration and listing
- description:
- - This query searches for all records with a particular `products.product_code`.
- params:
- - search for all records with `products.product_code` equal to `HQY`.
- - limit to 1 record.
- query: 'https://api.fda.gov/device/registrationlisting.json?search=products.product_code:HQY&limit=1'
-regulationNumber:
- title: One registrations and listings for 886.5850 regulation number
- description:
- - This query searches for records matching a certain search term, and asks for a single one.
- - See the [reference](/device/registrationlisting/reference/) for more fields you can use to narrow searches for device registrations and listings.
- params:
- - search for all records with `products.openfda.regulation_number` equals `886.5850`
- - limit to 1 record.
- query: 'https://api.fda.gov/device/registrationlisting.json?search=products.openfda.regulation_number:886.5850&limit=1'
-topClasses:
- title: Count of top device classes for device registrations and listings.
- description:
- - This query is similar to the prior one, but returns a count of the most device classes.
- - See the [reference](/device/registrationlisting/reference/) for more fields you can use to count and understand the nature of device adverse event reports.
- params:
- - search for all records.
- - count the field `products.openfda.device_class`
- query: 'https://api.fda.gov/device/registrationlisting.json?count=products.openfda.device_class'
\ No newline at end of file
diff --git a/pages/api_endpoints/device/registrationlisting/_fields.yaml b/pages/api_endpoints/device/registrationlisting/_fields.yaml
deleted file mode 100644
index 811d41a6..00000000
--- a/pages/api_endpoints/device/registrationlisting/_fields.yaml
+++ /dev/null
@@ -1,390 +0,0 @@
-properties:
- establishment_type:
- items:
- description: "Facility operation or activity, e.g. “Manufacturer” (short version)."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Manufacture Medical Device': "Manufacture Medical Device"
- 'Manufacture Medical Device for Another Party (Contract Manufacturer)': "Manufacture Medical Device for Another Party (Contract Manufacturer)"
- 'Repack or Relabel Medical Device': "Repack or Relabel Medical Device"
- 'Develop Specifications But Do Not Manufacture At This Facility': "Develop Specifications But Do Not Manufacture At This Facility"
- 'Sterilize Medical Device for Another Party (Contract Sterilizer)': "Sterilize Medical Device for Another Party (Contract Sterilizer)"
- 'Export Device to the United States But Perform No Other Operation on Device': "Export Device to the United States But Perform No Other Operation on Device"
- 'Complaint File Establishment per 21 CFR 820.198': "Complaint File Establishment per 21 CFR 820.198"
- 'Remanufacture Medical Device': "Remanufacture Medical Device"
- 'Manufacture Device in the United States for Export Only': "Manufacture Device in the United States for Export Only"
- 'Reprocess Single-Use Device': "Reprocess Single-Use Device"
- 'Foreign Private Label Distributor': "Foreign Private Label Distributor"
- type: string
- type: array
- k_number:
- description: "FDA-assigned premarket notification number, including leading letters. Leading letters “BK” indicates 510(k) clearance, or Premarket Notification, cleared by Center for Biologics Evaluation and Research. Leading letters “DEN” indicates De Novo, or Evaluation of Automatic Class III Designation. Leading letter “K” indicates 510(k) clearance, or Premarket Notification."
- format:
- is_exact: false
- possible_values:
- type: string
- pma_number:
- description: "FDA-assigned premarket application number, including leading letters. Leading letter “D” indicates Product Development Protocol type of Premarket Approval. Leading letters “BP” indicates Premarket Approval by Center for Biologics Evaluation and Research. Leading letter “H” indicates Humanitarian Device Exemption approval. Leading letter “N” indicates New Drug Application. Early PMAs were approved as NDAs. Leading letter “P” indicates Premarket Approval."
- format:
- is_exact: false
- possible_values:
- type: string
- products:
- items:
- properties:
- created_date:
- description: "Date listing was created (may be unreliable)."
- format: date
- is_exact: false
- possible_values:
- type: string
- exempt:
- description: "Flag indicating whether a device is exempt or not."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Y': "Yes"
- 'N': "No"
- type: string
- openfda:
- properties:
- device_class:
- description: "A risk based classification system for all medical devices (Federal Food, Drug, and Cosmetic Act, section 513). Additional information can be found [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm)."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "Class I (low to moderate risk): general controls"
- '2': "Class II (moderate to high risk): general controls and special controls"
- '3': "Class III (high risk): general controls and Premarket Approval (PMA)"
- 'U': "Unclassified"
- 'N': "Not classified"
- 'F': "HDE"
- type: string
- device_name:
- description: "This is the proprietary name, or trade name, of the cleared device."
- format:
- is_exact: true
- possible_values:
- type: string
- medical_specialty_description:
- description: "Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the “Regulation Medical Specialty” field."
- format:
- is_exact: true
- possible_values:
- type: string
- regulation_number:
- description: "The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device."
- format:
- is_exact: true
- possible_values:
- type: reference
- value:
- name: "CFR database"
- link: "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm"
- type: string
- type: object
- owner_operator_number:
- description: "Number assigned to Owner Operator by CDRH."
- format:
- is_exact: false
- possible_values:
- type: string
- product_code:
- description: "A three-letter identifier assigned to a device category. Assignment is based upon the medical device classification designated under 21 CFR Parts 862-892, and the technology and intended use of the device. Occasionally these codes are changed over time."
- format:
- is_exact: false
- possible_values:
- type: string
- type: object
- type: array
- proprietary_name:
- items:
- description: "Proprietary or brand name or model number a product is marketed under."
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- registration:
- properties:
- address_line_1:
- description: "Facility or US agent address line 1."
- format:
- is_exact: false
- possible_values:
- type: string
- address_line_2:
- description: "Facility or US agent address line 2."
- format:
- is_exact: false
- possible_values:
- type: string
- city:
- description: "Facility or US agent city."
- format:
- is_exact: true
- possible_values:
- type: string
- fei_number:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- initial_importer_flag:
- description: "Identifies whether facility is an initial importer."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Y': "Yes"
- 'N': "No"
- type: string
- iso_country_code:
- description: "Facility or US agent country code."
- format:
- is_exact: false
- possible_values:
- type: string
- name:
- description: "Name associated with the facility or US agent."
- format:
- is_exact: true
- possible_values:
- type: string
- owner_operator:
- properties:
- contact_address:
- properties:
- address_1:
- description: "First line of address for owner operator."
- format:
- is_exact: false
- possible_values:
- type: string
- address_2:
- description: "Second line of address for owner operator."
- format:
- is_exact: false
- possible_values:
- type: string
- city:
- description: "Owner operator city."
- format:
- is_exact: true
- possible_values:
- type: string
- iso_country_code:
- description: "Owner operator country code."
- format:
- is_exact: false
- possible_values:
- type: string
- postal_code:
- description: "Owner operator postal code."
- format:
- is_exact: true
- possible_values:
- type: string
- state_code:
- description: "Owner operator state code."
- format:
- is_exact: true
- possible_values:
- type: string
- state_province:
- description: "Owner operator province code."
- format:
- is_exact: true
- possible_values:
- type: string
- type: object
- firm_name:
- description: "Firm name of owner operator."
- format:
- is_exact: true
- possible_values:
- type: string
- official_correspondent:
- properties:
- first_name:
- description: "Official correspondent first name."
- format:
- is_exact: true
- possible_values:
- type: string
- last_name:
- description: "Official correspondent last name."
- format:
- is_exact: true
- possible_values:
- type: string
- middle_initial:
- description: "Official correspondent middle initial."
- format:
- is_exact: true
- possible_values:
- type: string
- phone_number:
- description: "Official correspondent phone number."
- format:
- is_exact: true
- possible_values:
- type: string
- subaccount_company_name:
- description: "Official correspondent company name (if different from owner operator company name)."
- format:
- is_exact: true
- possible_values:
- type: string
- type: object
- owner_operator_number:
- description: "Number assigned to Owner Operator by CDRH."
- format:
- is_exact: false
- possible_values:
- type: string
- type: object
- postal_code:
- description: "Facility foreign postal code."
- format:
- is_exact: true
- possible_values:
- type: string
- reg_expiry_date_year:
- description: "Year that registration expires (expires 12/31 of that year)."
- format:
- is_exact: false
- possible_values:
- type: string
- registration_number:
- description: "Facility identifier assigned to facility by the FDA Office of Regulatory Affairs."
- format:
- is_exact: false
- possible_values:
- type: string
- state_code:
- description: "Facility or US agent US state or foreign state or province."
- format:
- is_exact: false
- possible_values:
- type: string
- status_code:
- description: "Registration status code."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "Active"
- '5': "Active awaiting assignment of registration number"
- type: string
- us_agent:
- properties:
- address_line_1:
- description: "US agent address line 1."
- format:
- is_exact: false
- possible_values:
- type: string
- address_line_2:
- description: "US agent address line 2."
- format:
- is_exact: false
- possible_values:
- type: string
- bus_phone_area_code:
- description: "US agent phone area code."
- format:
- is_exact: false
- possible_values:
- type: string
- bus_phone_extn:
- description: "US agent phone extension."
- format:
- is_exact: false
- possible_values:
- type: string
- bus_phone_num:
- description: "US agent phone number."
- format:
- is_exact: true
- possible_values:
- type: string
- business_name:
- description: "Business name of US agent."
- format:
- is_exact: true
- possible_values:
- type: string
- city:
- description: "US agent city."
- format:
- is_exact: true
- possible_values:
- type: string
- email_address:
- description: "US agent email address."
- format:
- is_exact: true
- possible_values:
- type: string
- fax_area_code:
- description: "US agent fax area code."
- format:
- is_exact: false
- possible_values:
- type: string
- fax_num:
- description: "US agent fax phone number."
- format:
- is_exact: true
- possible_values:
- type: string
- iso_country_code:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- name:
- description: "US agent individual name."
- format:
- is_exact: true
- possible_values:
- type: string
- postal_code:
- description: "US agent country code."
- format:
- is_exact: true
- possible_values:
- type: string
- state_code:
- description: "US agent US state or foreign state or province."
- format:
- is_exact: false
- possible_values:
- type: string
- zip_code:
- description: "US agent zip code."
- format:
- is_exact: true
- possible_values:
- type: string
- type: object
- zip_code:
- description: "Facility or US agent Zip code."
- format:
- is_exact: true
- possible_values:
- type: string
- type: object
-type: object
diff --git a/pages/api_endpoints/device/registrationlisting/_infographics.yaml b/pages/api_endpoints/device/registrationlisting/_infographics.yaml
deleted file mode 100644
index 18711d54..00000000
--- a/pages/api_endpoints/device/registrationlisting/_infographics.yaml
+++ /dev/null
@@ -1,38 +0,0 @@
-- title: "Device registrations and listings by product code"
- short: "By product code"
- description:
- - "The name and product code identify the generic category of a device for FDA assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892."
- countParam: "products.product_code"
- filters:
- - title: "All registrations and listings"
- searchParam: ""
- - title: "Devices with the word *implant* in the name"
- searchParam: "device_name:implant"
- - title: "Proprietary name includes the term *pump*"
- searchParam: "proprietary_name:pump"
- - title: "*Device class I or II*"
- searchParam: "products.openfda.device_class:(1 OR 2)"
- filterByDate: false
- type: Bar
-- title: "Device registrations and listings by country"
- short: "By country"
- description:
- - "The country code on the postal delivery address of owner operator listed on the registration."
- countParam: "registration.owner_operator.contact_address.iso_country_code"
- filters:
- - title: "All registrations and listings"
- searchParam: ""
- - title: "All registrations and listings not in US"
- searchParam: "registration.iso_country_code:(NOT US)"
- - title: "Sunglasses (Non-Prescription Including Photosensitive)"
- searchParam: "products.product_code:HQY"
- - title: "Establishment type equals *Manufacture Medical Device*"
- searchParam: "establishment_type:Manufacture+Medical+Device"
- filterByDate: false
- type: Bar
-
-
-
-
-
-
diff --git a/pages/api_endpoints/device/registrationlisting/_meta.yaml b/pages/api_endpoints/device/registrationlisting/_meta.yaml
deleted file mode 100644
index c9f2df26..00000000
--- a/pages/api_endpoints/device/registrationlisting/_meta.yaml
+++ /dev/null
@@ -1,10 +0,0 @@
-type: endpoint
-documentTitle: openFDA › Device › Registrations and listings API
-label: Device registrations and listings
-title: Device Registrations and Listings
-description: The registration and listing dataset contains the location of medical device establishments and the devices manufactured at those establishments. Those who own or operate businesses involved in the production or distributions of medical devices are required to register with the FDA annually.
-datasets:
-path: /api_endpoints/device/registrationlisting
-api_path: /device/registrationlisting
-start:
-status: devicereglist
diff --git a/pages/api_endpoints/device/registrationlisting/index.jsx b/pages/api_endpoints/device/registrationlisting/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/device/registrationlisting/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/device/udi/_content.yaml b/pages/api_endpoints/device/udi/_content.yaml
deleted file mode 100644
index 85d75160..00000000
--- a/pages/api_endpoints/device/udi/_content.yaml
+++ /dev/null
@@ -1,89 +0,0 @@
-- "## About UDI"
-- "The *Global Unique Device Identification Database (GUDID)* contains key information submitted to the FDA about medical devices that have *Unique Device Identifiers (UDI)*."
-- "The FDA is establishing the unique device identification system to adequately identify devices sold in the U.S.- from manufacturing through distribution to patient use."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/device/udi.json` using search parameters for fields specific to the device UDI endpoint."
-- queryExplorer: oneCompanyMed
-- queryExplorer: oneBrandMed
-- "## Data reference"
-- "The openFDA unique device identifier API returns data from the Global Unique Device Identification Database (GUDID), which contains information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). UDIs are unique numeric or alphanumeric codes that consist of two parts—a device identifier (DI) and a production identifier (PI). UDIs are intended to increase electronic tracking abilities for devices involved in adverse events. Submission to the GUDID database is required for manufacturers of medical devices. To learn more about UDIs, see the FDA's [General information about UDI](http://www.fda.gov/udi) page."
-- "### Downloads"
-- "downloads"
-- "## How records are organized"
-- example: header
-- "## Results"
-- "For non-`count` queries, the `results` section includes matching unique device identifiers records returned by the API."
-- "## Field-by-field reference"
-- fields:
- - brand_name
- - catalog_number
- - commercial_distribution_end_date
- - commercial_distribution_status
- - company_name
- - device_count_in_base_package
- - device_description
- - has_donation_id_number
- - has_expiration_date
- - has_lot_or_batch_number
- - has_manufacturing_date
- - has_serial_number
- - is_combination_product
- - is_direct_marking_exempt
- - is_hct_p
- - is_kit
- - is_labeled_as_no_nrl
- - is_labeled_as_nrl
- - is_otc
- - is_pm_exempt
- - is_rx
- - is_single_use
- - mri_safety
- - publish_date
- - record_status
- - sterilization.is_sterile
- - sterilization.is_sterilization_prior_use
- - sterilization.sterilization_methods
- - product_codes.code
- - product_codes.name
- - version_or_model_number
-- "#### Device Identifiers"
-- "This section contains information on device identifier related fields."
-- fields:
- - identifiers.id
- - identifiers.issuing_agency
- - identifiers.package_discontinue_date
- - identifiers.package_status
- - identifiers.package_type
- - identifiers.quantity_per_package
- - identifiers.type
- - identifiers.unit_of_use_id
-- "#### Customer Contact"
-- "This section contains fields related to the customer contact for a device."
-- fields:
- - customer_contacts.email
- - customer_contacts.phone
-- "#### Device Size"
-- "This section contains information on device size related fields."
-- fields:
- - device_sizes.text
- - device_sizes.type
- - device_sizes.value
- - device_sizes.unit
-- "#### GMDN Terms"
-- "This section covers the fields that pertain to GMDN terms."
-- fields:
- - gmdn_terms.name
- - gmdn_terms.definition
-- "#### Storage and Handling"
-- "This section contains information on storage and handling related fields."
-- fields:
- - storage.high.value
- - storage.high.unit
- - storage.low.value
- - storage.low.unit
- - storage.special_conditions
- - storage.type
-- "### OpenFDA"
-- "The `openfda` section of each document is determined initially by looking at the product_code value."
-- fields:
- - product_codes.openfda
diff --git a/pages/api_endpoints/device/udi/_examples.json b/pages/api_endpoints/device/udi/_examples.json
deleted file mode 100644
index e737f513..00000000
--- a/pages/api_endpoints/device/udi/_examples.json
+++ /dev/null
@@ -1,76 +0,0 @@
-{
- "header" :
- {
- "has_donation_id_number": "false",
- "mri_safety": "Labeling does not contain MRI Safety Information",
- "record_status": "Published",
- "is_rx": "true",
- "is_labeled_as_nrl": "false",
- "commercial_distribution_status": "In Commercial Distribution",
- "device_description": "CoRoent Ant TLIF PEEK, 16x13x28mm 4°",
- "has_serial_number": "false",
- "sterilization": {
- "sterilization_methods": "Moist Heat or Steam Sterilization",
- "is_sterilization_prior_use": "true",
- "is_sterile": "false"
- },
- "is_direct_marking_exempt": "false",
- "is_labeled_as_no_nrl": "false",
- "is_single_use": "false",
- "identifiers": [
- {
- "issuing_agency": "GS1",
- "id": "00887517567062",
- "type": "Primary"
- }
- ],
- "is_otc": "false",
- "version_or_model_number": "5163284",
- "has_manufacturing_date": "false",
- "brand_name": "CoRoent",
- "is_combination_product": "false",
- "is_kit": "false",
- "product_codes": [
- {
- "code": "MAX",
- "name": "Intervertebral fusion device with bone graft, lumbar",
- "openfda": {
- "device_name": "Intervertebral Fusion Device With Bone Graft, Lumbar",
- "medical_specialty_description": "Orthopedic",
- "device_class": "2",
- "regulation_number": "888.3080"
- }
- },
- {
- "code": "MQP",
- "name": "SPINAL VERTEBRAL BODY REPLACEMENT DEVICE",
- "openfda": {
- "device_name": "Spinal Vertebral Body Replacement Device",
- "medical_specialty_description": "Orthopedic",
- "device_class": "2",
- "regulation_number": "888.3060"
- }
- }
- ],
- "device_count_in_base_package": "1",
- "has_lot_or_batch_number": "true",
- "customer_contacts": [
- {
- "phone": "+1(858)909-1800",
- "email": "fang.wei@fda.hhs.gov"
- }
- ],
- "company_name": "Nuvasive, Inc.",
- "has_expiration_date": "false",
- "is_hct_p": "false",
- "gmdn_terms": [
- {
- "name": "Metallic spinal fusion cage, non-sterile",
- "definition": "A non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use."
- }
- ],
- "is_pm_exempt": "false",
- "publish_date": "2015-10-24"
- }
-
-}
diff --git a/pages/api_endpoints/device/udi/_explorers.yaml b/pages/api_endpoints/device/udi/_explorers.yaml
deleted file mode 100644
index d44f31e1..00000000
--- a/pages/api_endpoints/device/udi/_explorers.yaml
+++ /dev/null
@@ -1,18 +0,0 @@
-oneCompanyMed:
- title: Record involving company name that contains "Nuvasive".
- description:
- - This query searches for records matching a certain search term.
- - See the [reference](/device/udi/reference/) for more fields you can use to narrow searches.
- params:
- - search for all records with `company_name` that contains `Nuvasive`.
- - limit to 1 record.
- query: 'https://api.fda.gov/device/udi.json?search=company_name:Nuvasive&limit=1'
-oneBrandMed:
- title: Record involving brand name that contains "Armada".
- description:
- - This query searches for records matching a certain search term.
- - See the [reference](/device/udi/reference/) for more fields you can use to narrow searches.
- params:
- - search for all records with `brand_name` that contains `Armada`.
- - limit to 1 record.
- query: 'https://api.fda.gov/device/udi.json?search=brand_name:Armada&limit=1&skip=50'
\ No newline at end of file
diff --git a/pages/api_endpoints/device/udi/_fields.yaml b/pages/api_endpoints/device/udi/_fields.yaml
deleted file mode 100644
index c76d2d67..00000000
--- a/pages/api_endpoints/device/udi/_fields.yaml
+++ /dev/null
@@ -1,598 +0,0 @@
-properties:
- brand_name:
- description: "The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. This information may 1) be on a label attached to a durable device, 2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol."
- format:
- is_exact: true
- possible_values:
- type: string
- catalog_number:
- description: "The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product."
- format:
- is_exact: true
- possible_values:
- type: string
- commercial_distribution_end_date:
- description: "Indicates the date the device is no longer held or offered for sale. See 21 CFR 807.3(b) for exceptions. The device may or may not still be available for purchase in the marketplace."
- format: date
- is_exact: false
- possible_values:
- type: date
- commercial_distribution_status:
- description: "Indicates whether the device is in commercial distribution as defined under 21 CFR 807.3(b)."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'In Commercial Distribution': "In Commercial Distribution"
- 'Not in Commercial Distribution': "Not in Commercial Distribution"
- type: string
- company_name:
- description: "Company name associated with the labeler DUNS Number entered in the DI Record."
- format:
- is_exact: true
- possible_values:
- type: string
- customer_contacts:
- items:
- properties:
- email:
- description: "Email for the Customer contact; to be used by patients and consumers for device-related questions."
- format:
- is_exact: false
- possible_values:
- type: string
- phone:
- description: "Phone number for the customer contact; to be used by patients and consumers for device-related questions."
- format:
- is_exact: false
- possible_values:
- type: string
- type: object
- type: array
- device_count_in_base_package:
- description: "Number of medical devices in the base package."
- format:
- is_exact: false
- possible_values:
- type: integer
- device_description:
- description: "Additional relevant information about the device that is not already captured as a distinct GUDID data attribute."
- format:
- is_exact: false
- possible_values:
- type: string
- device_sizes:
- items:
- properties:
- text:
- description: "Additional undefined device size not represented in the GUDID Size Type LOV."
- format:
- is_exact: false
- possible_values:
- type: string
- type:
- description: "Dimension type for the clinically relevant measurement of the medical device."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Circumference': "Circumference"
- 'Depth; Device Size Text, specify;': "Depth; Device Size Text, specify;"
- 'Catheter Gauge': "Catheter Gauge"
- 'Outer Diameter': "Outer Diameter"
- 'Height': "Height"
- 'Length': "Length"
- 'Lumen/Inner Diameter': "Lumen/Inner Diameter"
- 'Needle Gauge': "Needle Gauge"
- 'Total Volume': "Total Volume"
- 'Width': "Width"
- 'Weight': "Weight"
- 'Pressure': "Pressure"
- 'Pore Size': "Pore Size"
- 'Area/Surface Area': "Area/Surface Area"
- 'Angle': "Angle"
- type: string
- unit:
- description: "The unit of measure associated with each clinically relevant size."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Centiliter': "Centiliter"
- 'Centimeter': "Centimeter"
- 'Cubic Inch': "Cubic Inch"
- 'Cup': "Cup"
- 'Deciliter': "Deciliter"
- 'Decimeter': "Decimeter"
- 'degree': "degree"
- 'Feet': "Feet"
- 'Femtoliter': "Femtoliter"
- 'Femtometer': "Femtometer"
- 'Fluid Ounce': "Fluid Ounce"
- 'French': "French"
- 'Gallon': "Gallon"
- 'Gauge': "Gauge"
- 'Gram': "Gram"
- 'Hertz': "Hertz"
- 'Inch': "Inch"
- 'Kilogram': "Kilogram"
- 'Kiloliter': "Kiloliter"
- 'Kilometer': "Kilometer"
- 'KiloPascal': "KiloPascal"
- 'Liter': "Liter"
- 'Meter': "Meter"
- 'Microgram': "Microgram"
- 'Microliter': "Microliter"
- 'Micrometer': "Micrometer"
- 'millibar': "millibar"
- 'Milligram': "Milligram"
- 'Milliliter': "Milliliter"
- 'Millimeter': "Millimeter"
- 'Nanoliter': "Nanoliter"
- 'Nanometer': "Nanometer"
- 'Picoliter': "Picoliter"
- 'Picometer': "Picometer"
- 'Pint': "Pint"
- 'Pound': "Pound"
- 'Pound per Square Inch': "Pound per Square Inch"
- 'Quart': "Quart"
- 'Square centimeter': "Square centimeter"
- 'Square foot': "Square foot"
- 'Square inch': "Square inch"
- 'Square meter': "Square meter"
- 'Ton': "Ton"
- 'Yard': "Yard"
- type: string
- value:
- description: "Numeric value for the clinically relevant size measurement of the medical device."
- format: double
- is_exact: false
- possible_values:
- type: string
- type: object
- type: array
- gmdn_terms:
- items:
- properties:
- definition:
- description: "Definition of the common device type associated with the GMDN Preferred Term Code/FDA PT Code."
- format:
- is_exact: false
- possible_values:
- type: string
- name:
- description: "Name of the common device type associated with the GMDN Preferred Term Code/FDA PT Code."
- format:
- is_exact: true
- possible_values:
- type: string
- type: object
- type: array
- has_donation_id_number:
- description: "The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation.This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- has_expiration_date:
- description: "The date by which the label of a device states the device must or should be used. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- has_lot_or_batch_number:
- description: "The number assigned to one or more device(s) that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- has_manufacturing_date:
- description: "The date on which a device is manufactured.This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- has_serial_number:
- description: "The number that allows for the identification of a device, indicating its position within a series. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- identifiers:
- items:
- properties:
- id:
- description: "An identifier that is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use. The primary DI number will be located on the base package, which is the lowest package level of a medical device containing a full UDI. For medical devices without packaging, the primary DI number and full UDI may be on the device itself."
- format:
- is_exact: false
- possible_values:
- type: string
- issuing_agency:
- description: "Organization accredited by FDA to operate a system for the issuance of UDIs"
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'GS1': "GS1"
- 'ICCBBA': "ICCBBA"
- 'HIBCC': "HIBCC"
- 'NDC/NHRIC': "NDC/NHRIC"
- type: string
- package_discontinue_date:
- description: "Indicates the date this particular package configuration is discontinued by the Labeler or removed from the marketplace."
- format: date
- is_exact: false
- possible_values:
- type: date
- package_status:
- description: "Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b)."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'In Commercial Distribution': "In Commercial Distribution"
- 'Not in Commercial Distribution': "Not in Commercial Distribution"
- type: string
- package_type:
- description: "The type of packaging used for the device."
- is_exact: false
- possible_values:
- type: string
- quantity_per_package:
- description: "The number of packages with the same Primary DI or Package DI within a given packaging configuration."
- format:
- is_exact: false
- possible_values:
- type: integer
- type:
- description: "Indicates whether the identifier is the Primary, Secondary, Direct Marking, Unit of Use, Package, or Previous DI"
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Primary': "Primary DI. An identifier that is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use. The primary DI number will be located on the base package, which is the lowest package level of a medical device containing a full UDI. For medical devices without packaging, the primary DI number and full UDI may be on the device itself."
- 'Secondary': "Secondary DI. An identifier that is an alternate (secondary) lookup for a medical device that is issued from a different issuing agency than the primary DI. Under 21 CFR 830.40(a), only one device identifier from any particular system for the issuance of UDIs may be used to identify a particular version or model of a device."
- 'Direct Marking': "Direct Marking DI. An identifier that is marked directly on the medical device and is different than the Primary DI Number; only applicable to devices subject to Direct Marking requirements under 21 CFR 801.45."
- 'Unit of Use': "Unit of Use DI. An identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient."
- 'Package': "Package DI. A device identifier for the package configuration that contains multiple units of the base package (does not include shipping containers)."
- 'Previous DI': "Previous DI"
- type: string
- unit_of_use_id:
- description: "An identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient. Unit of Use DI is an identifier used by hospital staff and Materials Management to account for a single device when the UDI is labeled on a higher level of packaging. The Unit of Use DI does not appear on the label. Data type and field length are determined by the individual Issuing Agency structure."
- format:
- is_exact: false
- possible_values:
- type: string
- type: object
- type: array
- is_combination_product:
- description: "Indicates that the product is comprised of two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity; packaged together as a single package; or packaged separately for the intended use together as defined under 21 CFR 3.2(e). At least one of the products in the combination product must be a device in this case."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_direct_marking_exempt:
- description: "The device is exempt from Direct Marking requirements under 21 CFR 801.45."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_hct_p:
- description: "Indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_kit:
- description: "Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and are being distributed as a medical device."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_labeled_as_no_nrl:
- description: "Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information. Only applicable to devices not subject to the requirements under 21 CFR 801.437. Not all medical products that are NOT made with natural rubber latex will be marked."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_labeled_as_nrl:
- description: "Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. The value `true` indicates that the device label or packaging contains one of the following statements: (1) 'Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions', (2) 'This Product Contains Dry Natural Rubber', (3) 'Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions' or (4) 'The Packaging of This Product Contains Dry Natural Rubber'."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_otc:
- description: "Indicates that the device does not require a prescription to use and can be purchased over the counter."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_pm_exempt:
- description: "Indicates whether the device is exempt from premarket notification requirements."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_rx:
- description: "Indicates whether the device requires a prescription."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_single_use:
- description: "Indicates that the device is intended for one use or on a single patient during a single procedure."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- mri_safety:
- description: "Indicates the MRI Safety Information, if any, that is present in the device labeling. Please see the ASTM F2503-13 standard for more information."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'MR Safe': "MR Safe"
- 'MR Unsafe': "MR Unsafe"
- 'MR Conditional': "MR Conditional"
- 'Labeling does not contain MRI Safety Information': "Labeling does not contain MRI Safety Information"
- type: string
- product_codes:
- items:
- properties:
- code:
- description: "A three-letter identifier assigned to a device category"
- format:
- is_exact: true
- possible_values:
- type: string
- name:
- description: "Name associated with the three-letter Product Code"
- format:
- is_exact: false
- possible_values:
- type: string
- openfda:
- type: object
- properties:
- device_class:
- description: "A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- '1': "Class I (low to moderate risk): general controls"
- '2': "Class II (moderate to high risk): general controls and special controls"
- '3': "Class III (high risk): general controls and Premarket Approval (PMA)"
- 'U': "Unclassified"
- 'N': "Not classified"
- 'F': "HDE"
- type: string
- device_name:
- description: "This is the proprietary name, or trade name, of the cleared device."
- format:
- is_exact: true
- possible_values:
- type: string
- medical_specialty_description:
- description: "Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the 'Regulation Medical Specialty' field."
- format:
- is_exact: true
- possible_values:
- type: string
- regulation_number:
- description: "The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device."
- format:
- is_exact: true
- possible_values:
- type: string
- type: object
- type: array
- publish_date:
- description: "Indicates the date the DI Record gets published and is available via Public Search."
- format: date
- is_exact: false
- possible_values:
- type: date
- record_status:
- description: "Indicates the status of the DI Record."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Published': "Published"
- 'Unpublished': "Unpublished"
- 'Deactivated': "Deactivated"
- type: string
- sterilization:
- type: object
- properties:
- is_sterile:
- description: "Indicates the medical device is free from viable microorganisms. See ISO/TS 11139."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- is_sterilization_prior_use:
- description: "Indicates that the device requires sterilization prior to use."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'true': 'true'
- 'false': 'false'
- type: boolean
- sterilization_methods:
- description: " Indicates the method(s) of sterilization that can be used for this device."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Chlorine Dioxide': "Chlorine Dioxide"
- 'Dry Heat Sterilization': "Dry Heat Sterilization"
- 'Ethylene Oxide': "Ethylene Oxide"
- 'High Intensity Light or Pulse Light': "High Intensity Light or Pulse Light"
- 'High-level Disinfectant': "High-level Disinfectant"
- 'Hydrogen Peroxide': "Hydrogen Peroxide"
- 'Liquid Chemical': "Liquid Chemical"
- 'Microwave Radiation': "Microwave Radiation"
- 'Moist Heat or Steam Sterilization': "Moist Heat or Steam Sterilization"
- 'Nitrogen Dioxide': "Nitrogen Dioxide"
- 'Ozone': "Ozone"
- 'Peracetic Acid': "Peracetic Acid"
- 'Radiation Sterilization': "Radiation Sterilization"
- 'Sound Waves': "Sound Waves"
- 'Supercritical Carbon Dioxide': "Supercritical Carbon Dioxide"
- 'Ultraviolet Light': "Ultraviolet Light"
- type: string
- storage:
- items:
- properties:
- high:
- properties:
- unit:
- description: "The high value unit of measure associated with the storage and handling conditions."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Degrees Celsius': "Degrees Celsius"
- 'Degrees Fahrenheit': "Degrees Fahrenheit"
- 'Degrees Kelvin': "Degrees Kelvin"
- 'Kilo Pascal': "Kilo Pascal"
- 'Percent (%) Relative Humidity, Millibar': "Percent (%) Relative Humidity,Millibar"
- type: string
- value:
- description: "Indicates the high value for storage and handling requirements."
- format:
- is_exact: false
- possible_values:
- type: string
- type: object
- low:
- properties:
- unit:
- description: "The low value unit of measure associated with the storage and handling conditions."
- format:
- is_exact: false
- possible_values:
- type: string
- value:
- description: "Indicates the low value for storage and handling requirements."
- format:
- is_exact: false
- possible_values:
- type: one_of
- value:
- 'Degrees Celsius': "Degrees Celsius"
- 'Degrees Fahrenheit': "Degrees Fahrenheit"
- 'Degrees Kelvin': "Degrees Kelvin"
- 'Kilo Pascal': "Kilo Pascal"
- 'Percent (%) Relative Humidity, Millibar': "Percent (%) Relative Humidity,Millibar"
- type: string
- type: object
- special_conditions:
- description: "Indicates any special storage requirements for the device."
- format:
- is_exact: true
- possible_values:
- type: string
- type:
- description: "Indicates storage and handling requirements for the device including temperature, humidity, and atmospheric pressure."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- 'Handling Environment Atmospheric Pressure': "Handling Environment Atmospheric Pressure"
- 'Handling Environment Humidity': "Handling Environment Humidity"
- 'Handling Environment Temperature': "Handling Environment Temperature"
- 'Special Storage Conditions': "Special Storage Conditions"
- 'Storage Environment Atmospheric Pressure': "Storage Environment Atmospheric Pressure"
- 'Storage Environment Humidity': "Storage Environment Humidity"
- 'Storage Environment Temperature': "Storage Environment Temperature"
- type: string
- type: object
- type: array
- version_or_model_number:
- description: "The version or model found on the device label or accompanying packaging used to identify a category or design of a device. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler."
- format:
- is_exact: true
- possible_values:
- type: string
-type: object
diff --git a/pages/api_endpoints/device/udi/_infographics.yaml b/pages/api_endpoints/device/udi/_infographics.yaml
deleted file mode 100644
index b18efde1..00000000
--- a/pages/api_endpoints/device/udi/_infographics.yaml
+++ /dev/null
@@ -1,42 +0,0 @@
-- title: "UDI Listing by Brand Name"
- short: "By Brand Name"
- description:
- - "This chart is generated based on queries against the UDI API endpoint. The chart is provided here to help illustrate how the UDI data can be queried and used. You can interact with the chart by (1) selecting a different filter (which changes the search parameter) or by (2) selecting a different field from the drop down list (which changes the field used to count the results). For example, observe how the results differ if you count using brand_name.exact rather than brand_name."
- countParam: "brand_name.exact"
- filters:
- - title: "All UDI"
- searchParam: ""
- - title: "For single use only"
- searchParam: "is_single_use:true"
- filterByDate: false
- type: Line
-- title: "UDI Listing by Company Name"
- short: "By Company Name"
- description:
- - "This chart is generated based on queries against the UDI API endpoint. The chart is provided here to help illustrate how the UDI data can be queried and used. You can interact with the chart by (1) selecting a different filter (which changes the search parameter) or by (2) selecting a different field from the drop down list (which changes the field used to count the results). For example, observe how the results differ if you count using company_name.exact rather than company_name."
- countParam: "company_name.exact"
- filters:
- - title: "All UDI"
- searchParam: ""
- - title: "Available over the counter"
- searchParam: "is_otc:true"
- filterByDate: false
- type: Bar
-- title: "UDI Listing by Product Code"
- short: "By Product Code"
- description:
- - "This chart is generated based on queries against the UDI API endpoint. The chart is provided here to help illustrate how the UDI data can be queried and used. You can interact with the chart by (1) selecting a different filter (which changes the search parameter) or by (2) selecting a different field from the drop down list (which changes the field used to count the results)."
- countParam: "product_codes.code"
- filters:
- - title: "All UDI"
- searchParam: ""
- - title: "By Medical Speciality associated with product_code"
- searchParam: "product_codes.openfda.medical_specialty_description:Surgery"
- filterByDate: false
- type: Bar
-
-
-
-
-
-
diff --git a/pages/api_endpoints/device/udi/_meta.yaml b/pages/api_endpoints/device/udi/_meta.yaml
deleted file mode 100644
index 1b7c3fae..00000000
--- a/pages/api_endpoints/device/udi/_meta.yaml
+++ /dev/null
@@ -1,11 +0,0 @@
-type: endpoint
-documentTitle: openFDA › Device › UDI
-label: Unique device identifier
-title: Unique Device Identifier
-description: The unique device identification system was established to identify devices through distribution and use. Device labelers are required to include a unique device identifier (UDI) on device labels and packages. The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA.
-endpoint: device/udi
-datasets:
-path: /api_endpoints/device/udi
-api_path: /device/udi
-start:
-status: deviceudi
\ No newline at end of file
diff --git a/pages/api_endpoints/device/udi/index.jsx b/pages/api_endpoints/device/udi/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/device/udi/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/drug/_content.yaml b/pages/api_endpoints/drug/_content.yaml
deleted file mode 100644
index f005f0da..00000000
--- a/pages/api_endpoints/drug/_content.yaml
+++ /dev/null
@@ -1,12 +0,0 @@
-- url: /drug/event/
- title: Drug adverse events
- description:
- - "Reports of drug side effects, product use errors, product quality problems, and therapeutic failures."
-- url: /drug/label/
- title: Drug product labeling
- description:
- - "Structured product information, including prescribing information, for approved drug products."
-- url: /drug/enforcement/
- title: Drug recall enforcement reports
- description:
- - "Drug product recall enforcement reports."
diff --git a/pages/api_endpoints/drug/_meta.yaml b/pages/api_endpoints/drug/_meta.yaml
deleted file mode 100644
index 50cf1abe..00000000
--- a/pages/api_endpoints/drug/_meta.yaml
+++ /dev/null
@@ -1,6 +0,0 @@
-documentTitle: openFDA › Drugs
-label: API categories
-title: Drugs
-description: "The U.S. Food and Drug Administration (FDA) regulates over-the-counter and prescription drugs in the United States, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos, and sunscreens are all considered drugs."
-path: /api_endpoints/drug
-type: noun
diff --git a/pages/api_endpoints/drug/_template.jsx b/pages/api_endpoints/drug/_template.jsx
deleted file mode 100644
index b9e477f8..00000000
--- a/pages/api_endpoints/drug/_template.jsx
+++ /dev/null
@@ -1,2 +0,0 @@
-import React from 'react'
-export default (props) => props.children
diff --git a/pages/api_endpoints/drug/enforcement/_content.yaml b/pages/api_endpoints/drug/enforcement/_content.yaml
deleted file mode 100644
index 643b1d87..00000000
--- a/pages/api_endpoints/drug/enforcement/_content.yaml
+++ /dev/null
@@ -1,84 +0,0 @@
-- "## About drug recalls and enforcement reports"
-- "Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA). Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or civil actions, especially when the product has been widely distributed."
-- "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
-- "## Enforcement reports"
-- "An enforcement report contains information on actions taken in connection with FDA regulatory activities. The data served by this API endpoint includes enforcement reports about drug product recalls."
-- "This API should not be used as a method to collect data to issue alerts to the public. FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. Subscribe to this Recall/Safety Alert feed here."
-- "Whereas not all recalls are announced in the media or on our recall press release page all FDA-monitored recalls go into FDA’s Enforcement Report once they are classified according to the level of hazard involved. For more information, see FDA 101: Product Recalls from First Alert to Effectiveness Checks."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/drug/enforcement.json` using search parameters for fields specific to the drug enforcement endpoint."
-- queryExplorer: oneReport
-- queryExplorer: hazard
-- queryExplorer: voluntaryVsMandated
-- "## Data reference"
-- "The openFDA drug enforcement reports API returns data from the [FDA Recall Enterprise System (RES)](/data/res/), a database that contains information on recall event information submitted to FDA. Currently, this data covers publically releasable records from 2004-present. The data is updated weekly."
-- "The procedures followed to input recall information into RES when FDA learns of a recall event are outlined in [Chapter 7 of FDA’s Regulatory Procedure Manual](http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm177304.htm). The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters."
-- disclaimer:
- - "This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall. FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. [Subscribe to this Recall/Safety Alert feed here](http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Recalls/rss.xml)."
- - "Further, FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports."
-- "When necessary, the FDA will make corrections or changes to recall information previously disclosed in a past Enforcement Report for various reasons. For instance, the firm may discover that the initial recall should be expanded to include more batches or lots of the same recalled product than formerly reported. For more information about corrections or changes implemented, please refer to the Enforcement Report’s [Changes to Past Enforcement Reports” page](http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm345487.htm)."
-- "### What are enforcement reports?"
-- "An enforcement report contains information on actions taken in connection with FDA regulatory activities. The data served by this API endpoint includes enforcement reports about drug product recalls."
-- "Whereas not all recalls are announced in the media or on [FDA’s Recalls press release page](http://www.fda.gov/Safety/recalls/default.htm), all recalls montiored by FDA are included in [FDA’s weekly Enforcement Report](http://www.fda.gov/%20Safety/Recalls/EnforcementReports/default.htm) once they are classified according to the level of hazard involved."
-- "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
-- "### Downloads"
-- "downloads"
-- "### Anatomy of a response"
-- "This is a simulated openFDA API return for a non-`count` query. It is divided into two high-level sections, `meta` and `results`."
-- example: anatomy
-- "### Meta"
-- "For non-`count` queries, the `meta` section includes a disclaimer, a link to the openFDA data license, and information about the results that follow."
-- example: meta
-- fields:
- - meta.disclaimer
- - meta.license
- - meta.last_updated
- - meta.results.skip
- - meta.results.limit
- - meta.results.total
-- "### Results"
-- "For non-`count` queries, the `results` section includes matching enforcement report records returned by the API."
-- "Each enforcement report record consists of two sets of fields:"
-- ul:
- - "Enforcement report data"
- - "An **openfda** section: An annotation with additional product identifiers, such as UPC and brand name, of the drug products listed in the enforcement report, if available"
-- "The data format of RES enforcement reports changed in June 2012. In openFDA API results, reports from before that time do not contain the following fields:"
-- ul:
- - "`event_id`"
- - "`status`"
- - "`city`"
- - "`state`"
- - "`country`"
- - "`voluntary_mandated`"
- - "`initial_firm_notification`"
- - "`recall_initiation_date`"
-- "## Field-by-field reference"
-- "### Enforcement report"
-- example: result
-- fields:
- - recalling_firm
- - classification
- - status
- - distribution_pattern
- - product_description
- - code_info
- - reason_for_recall
- - product_quantity
- - voluntary_mandated
- - report_date
- - recall_initiation_date
- - initial_firm_notification
- - recall_number
- - event_id
- - product_type
-- "### Geographic data"
-- fields:
- - city
- - state
- - country
-- "### OpenFDA fields"
-- "For more information about the `openfda` section, see the [API reference](/api/reference/)."
-- "Different datasets use different drug identifiers—brand name, generic name, NDA, NDC, etc. It can be difficult to find the same drug in different datasets. And some identifiers, like pharmacologic class, are useful search filters but not available in all datasets."
-- "OpenFDA features harmonization of drug identifiers, to make it easier to search enforcement report records by more identifiers, like product type (OTC versus prescription). Drug products that appear in enforcement reports are harmonized on NDC or UPC, if available. **The linked data is listed as an `openfda` annotation in the `patient.drug` section of a result.**"
-- "Roughly half of enforcement reports have an `openfda` section. Because the harmonization process requires an exact match, some drug products cannot be harmonized in this fashion—for instance, if there is no NDC or UPC in the original enforcement report, there will be no `openfda` section."
-- "datasets"
diff --git a/pages/api_endpoints/drug/enforcement/_examples.json b/pages/api_endpoints/drug/enforcement/_examples.json
deleted file mode 100644
index 5d3b6ce6..00000000
--- a/pages/api_endpoints/drug/enforcement/_examples.json
+++ /dev/null
@@ -1,49 +0,0 @@
-{
- "anatomy": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- },
- "results": [
- {}
- ]
- },
- "meta": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- }
- },
- "result": {
- "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..",
- "status": "Ongoing",
- "distribution_pattern": "Nationwide and Puerto Rico, and Panama.\nMilitary distribution made.",
- "product_quantity": "99,660 tubes",
- "recall_initiation_date": "2013-02-19",
- "state": "NE",
- "event_id": "64372",
- "product_type": "Drugs",
- "product_description": "Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN.",
- "country": "US",
- "city": "Lincoln",
- "recalling_firm": "Novartis Consumer Health",
- "report_date": "2013-06-12",
- "voluntary_mandated": "Voluntary: Firm Initiated",
- "classification": "Class III",
- "code_info": "Lot numbers and exp dates: 10108716 31-Mar-2013, \n10111510 30-Apr-2013, 10113801 31-May-2013, 10113839 30-Apr-2013, 10115616 31-Aug-2013",
- "openfda": {},
- "initial_firm_notification": "Letter"
- }
-}
diff --git a/pages/api_endpoints/drug/enforcement/_explorers.yaml b/pages/api_endpoints/drug/enforcement/_explorers.yaml
deleted file mode 100644
index c7323cc8..00000000
--- a/pages/api_endpoints/drug/enforcement/_explorers.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-oneReport:
- title: One enforcement report
- description:
- - "This query searches for all records in a certain date range, and asks for a single one."
- - "See the [reference](/drug/enforcement/reference/) for more about report_date. Brackets `[ ]` are used to specify a range for date, number, or string fields."
- params:
- - "Search for all records with report_date between Jan 01, 2004 and Dec 31, 2013."
- - "Limit to 1 record."
- query: 'https://api.fda.gov/drug/enforcement.json?search=report_date:[20040101+TO+20131231]&limit=1'
-hazard:
- title: One enforcement report of a certain health hazard class
- description:
- - "This query searches records of a certain health hazard, and returns a single record."
- - 'Double quotation marks `" "` surround phrases that must match exactly. The plus sign + is used in place of a space character ` `.'
- params:
- - "Search for all records where classification (health hazard level) was Class III."
- - "Limit to 1 record."
- query: 'https://api.fda.gov/drug/enforcement.json?search=classification:"Class+III"&limit=1'
-voluntaryVsMandated:
- title: "Count of voluntary vs. mandated enforcement reports"
- description:
- - "The vast majority of recalls are firm-initiated. This query searches the endpoint for all records, and tells the API to count how many enforcement reports were for voluntary vs. FDA-mandated recalls."
- - "The suffix .exact is required by openFDA to count the unique full phrases in the field voluntary_mandated. Without it, the API will count each word in that field individually—Firm Initiated would be counted as separate values, Firm and Initiated."
- params:
- - "Count the field `voluntary_mandated` (type of recall)."
- query: 'https://api.fda.gov/drug/enforcement.json?count=voluntary_mandated.exact'
diff --git a/pages/api_endpoints/drug/enforcement/_fields.yaml b/pages/api_endpoints/drug/enforcement/_fields.yaml
deleted file mode 100644
index 3c383aa5..00000000
--- a/pages/api_endpoints/drug/enforcement/_fields.yaml
+++ /dev/null
@@ -1,213 +0,0 @@
-properties:
- address_1:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- address_2:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- center_classification_date:
- description:
- format: date
- is_exact: false
- possible_values:
- type: string
- city:
- description: "The city in which the recalling firm is located."
- format:
- is_exact: true
- possible_values:
- type: string
- classification:
- description: "Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- "Class I": "Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve."
- "Class II": "Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations."
- "Class III": "Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food."
- type: string
- code_info:
- description: "A list of all lot and/or serial numbers, product numbers, packer or manufacturer numbers, sell or use by dates, etc., which appear on the product or its labeling."
- format:
- is_exact: false
- possible_values:
- type: string
- country:
- description: "The country in which the recalling firm is located."
- format:
- is_exact: true
- possible_values:
- type: string
- distribution_pattern:
- description: "General area of initial distribution such as, “Distributors in 6 states: NY, VA, TX, GA, FL and MA; the Virgin Islands; Canada and Japan”. The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included."
- format:
- is_exact: false
- possible_values:
- type: string
- event_id:
- description: "A numerical designation assigned by FDA to a specific recall event used for tracking purposes."
- format: int64
- is_exact: false
- possible_values:
- type: string
- initial_firm_notification:
- description: "The method(s) by which the firm initially notified the public or their consignees of a recall. A consignee is a person or firm named in a bill of lading to whom or to whose order the product has or will be delivered."
- format:
- is_exact: true
- possible_values:
- type: string
- more_code_info:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- product_type:
- description: "The type of product being recalled. For drug queries, this will always be `Drugs`."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- "Drugs": "The recalled product is a drug product."
- "Devices": "The recalled product is a device product."
- "Food": "The recalled product is a food product."
- product_code:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- product_description:
- description: "Brief description of the product being recalled."
- format:
- is_exact: false
- possible_values:
- type: string
- product_quantity:
- description: "The amount of defective product subject to recall."
- format:
- is_exact: false
- possible_values:
- type: string
- reason_for_recall:
- description: "Information describing how the product is defective and violates the FD&C Act or related statutes."
- format:
- is_exact: false
- possible_values:
- type: string
- recall_initiation_date:
- description: "Date that the firm first began notifying the public or their consignees of the recall."
- format: date
- is_exact: false
- possible_values:
- type: string
- recall_number:
- description: "A numerical designation assigned by FDA to a specific recall event used for tracking purposes."
- format:
- is_exact: true
- possible_values:
- type: string
- recalling_firm:
- description: "The firm that initiates a recall or, in the case of an FDA requested recall or FDA mandated recall, the firm that has primary responsibility for the manufacture and (or) marketing of the product to be recalled."
- format:
- is_exact: true
- possible_values:
- type: string
- report_date:
- description: "Date that the FDA issued the enforcement report for the product recall."
- format: date
- is_exact: false
- possible_values:
- type: string
- state:
- description: "The U.S. state in which the recalling firm is located."
- format:
- is_exact: true
- possible_values:
- type: string
- status:
- description:
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- "On-Going": "A recall which is currently in progress."
- "Completed": "The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections."
- "Terminated": "FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard."
- "Pending": "Actions that have been determined to be recalls, but that remain in the process of being classified."
- type: string
- termination_date:
- description:
- format: date
- is_exact: false
- possible_values:
- type: string
- voluntary_mandated:
- description: "Describes who initiated the recall. Recalls are almost always voluntary, meaning initiated by a firm. A recall is deemed voluntary when the firm voluntarily removes or corrects marketed products or the FDA requests the marketed products be removed or corrected. A recall is mandated when the firm was ordered by the FDA to remove or correct the marketed products, under section 518(e) of the FD&C Act, National Childhood Vaccine Injury Act of 1986, 21 CFR 1271.440, Infant Formula Act of 1980 and its 1986 amendments, or the Food Safety Modernization Act (FSMA)."
- format:
- is_exact: true
- possible_values:
- type: string
- meta:
- format:
- type: object
- description: 'This section contains a disclaimer and license information. The field `last_updated` indicates when the data files were exported.'
- possible_values:
- properties:
- type: object
- disclaimer:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Important details notes about openFDA data and limitations of the dataset."
- possible_values:
- license:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Link to a web page with license terms that govern data within openFDA."
- possible_values:
- last_updated:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "The last date when this openFDA endpoint was updated. Note that this does not correspond to the most recent record for the endpoint or dataset. Rather, it is the last time the openFDA API was itself updated."
- possible_values:
- results:
- type: object
- properties:
- skip:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Offset (page) of results, defined by the `skip` [query parameter](/api/)."
- possible_values:
- limit:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Number of records in this return, defined by the `limit` [query parameter](/api/). If there is no `limit` parameter, the API returns one result."
- possible_values:
- total:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Total number of records matching the search criteria."
- possible_values:
- type: object
\ No newline at end of file
diff --git a/pages/api_endpoints/drug/enforcement/_infographics.yaml b/pages/api_endpoints/drug/enforcement/_infographics.yaml
deleted file mode 100644
index 7956f4ba..00000000
--- a/pages/api_endpoints/drug/enforcement/_infographics.yaml
+++ /dev/null
@@ -1,41 +0,0 @@
-- title: "Drug recall enforcement reports since 2012"
- short: "Enforcement reports over time"
- description:
- - "This is the openFDA API endpoint for all drug product recalls monitored by the FDA. When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public."
- - "Recalls are almost always voluntary, meaning a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request or order a recall. But in every case, FDA's role is to oversee a company's strategy, classify the recalled products according to the level of hazard involved, and assess the adequacy of the recall. Recall information is posted in the Enforcement Reports once the products are classified."
- - "Only about half of the enforcement reports in the API have an openfda section with information about whether the drug product involved was an over-the-counter or prescription product."
- countParam: "report_date"
- filters:
- - title: "All drug product enforcement reports"
- searchParam: ""
- - title: "Over-the-counter drugs"
- searchParam: "openfda.product_type:otc"
- - title: "Prescription drugs"
- searchParam: "openfda.product_type:prescription"
- type: Line
- dateConstraint: false
-- title: "The vast majority of drug recalls are voluntary"
- short: "Who initiates?"
- description:
- - "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
- countParam: "voluntary_mandated.exact"
- filters:
- - title: "All drug product enforcement reports"
- searchParam: ""
- type: Donut
- dateConstraint: false
-- title: "Most drug product recalls are Class II"
- short: "Seriousness"
- description:
- - "Recalls are classified into three categories: Class I, a dangerous or defective product that predictably could cause serious health problems or death, Class II, meaning that the product might cause a temporary health problem, or pose only a slight threat of a serious nature, and Class III, a product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws."
- - "Note that only about half of the enforcement reports in the API have an openfda section with information about whether the drug product involved was an over-the-counter or prescription product."
- countParam: "classification.exact"
- filters:
- - title: "All drug product enforcement reports"
- searchParam: ""
- - title: "Over-the-counter drugs"
- searchParam: "openfda.product_type:otc"
- - title: "Prescription drugs"
- searchParam: "openfda.product_type:prescription"
- type: Donut
- dateConstraint: false
diff --git a/pages/api_endpoints/drug/enforcement/_meta.yaml b/pages/api_endpoints/drug/enforcement/_meta.yaml
deleted file mode 100644
index 3ae4a136..00000000
--- a/pages/api_endpoints/drug/enforcement/_meta.yaml
+++ /dev/null
@@ -1,12 +0,0 @@
-documentTitle: openFDA › Drugs › Recall enforcement reports API
-label: Drug recall enforcement reports
-title: Drug Recall Enforcement Reports
-description: "Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA)."
-datasets:
- - RES
-path: /api_endpoints/drug/enforcement
-api_path: /drug/enforcement
-start: 20090101
-status: drugenforcement
-dateConstraintKey: termination_date
-type: endpoint
diff --git a/pages/api_endpoints/drug/enforcement/index.jsx b/pages/api_endpoints/drug/enforcement/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/drug/enforcement/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/drug/event/_content.yaml b/pages/api_endpoints/drug/event/_content.yaml
deleted file mode 100644
index bc07787f..00000000
--- a/pages/api_endpoints/drug/event/_content.yaml
+++ /dev/null
@@ -1,127 +0,0 @@
-- "## About drug adverse events"
-- "The U.S. Food and Drug Administration (FDA) regulates over-the-counter and prescription drugs in the United States, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered drugs."
-- "An adverse event is submitted to the FDA to report any undesirable experience associated with the use of a medical product in a patient. For drugs, this includes serious drug side effects, product use errors, product quality problems, and therapeutic failures for prescription or over-the-counter medicines and medicines administered to hospital patients or at outpatient infusion centers."
-- "### Adverse event reports"
-- "This highly simplified schematic illustrates the general nature of an adverse event report. A report may list several drug products, as well as several patient reactions. No individual drug is connected to any individual reaction. **When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.**"
-- "image"
-- "Any number of the drugs may be marked as *suspect* if thought to be responsible for one or more of the reactions, but that information is not validated. *Concomitant* drugs are those which are not suspected of causing one or more of the reactions. Many drug products appear frequently in adverse event reports simply because they are commonly taken by many people in the population, not because they are responsible for more adverse events."
-- "Reports contain varying levels of detail about the drug products involved, indications for use, route of administration, and dose."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/drug/event.json` using search parameters for fields specific to the drug adverse events endpoint."
-- queryExplorer: oneReport
-- queryExplorer: pharmacologic
-- queryExplorer: reaction
-- "## Data reference"
-- "The openFDA drug adverse event API returns data from the [FDA Adverse Event Reporting System (FAERS)](/data/faers/), a database that contains information on adverse event and medication error reports submitted to FDA. Currently, this data covers publically releasable records submitted to the FDA from 2004-2013. The data is updated quarterly."
-- "An adverse event is submitted to the FDA to report any undesirable experience associated with the use of a medical product in a patient. For drugs, this includes serious drug side effects, product use errors, product quality problems, and therapeutic failures for prescription or over-the-counter medicines and medicines administered to hospital patients or at outpatient infusion centers."
-- "Reporting of adverse events by healthcare professionals and consumers is voluntary in the United States. FDA receives some adverse event reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report adverse events to the products’ manufacturers. If a manufacturer receives an adverse event report, it is normally required to send the report to FDA."
-- disclaimer:
- - "FAERS data does have limitations. There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event."
- - "Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event."
- - "Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events."
-- "In 2012, FDA changed from the Adverse Event Reporting System (AERS) to the FDA Adverse Event Reporting System (FAERS). There was a minor shift in terms as part of this transition. If you are using data from before December 2012, you should be aware of this shift."
-- "### Responsible use of the data"
-- "Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, **a causal relationship cannot be established between product and reactions listed in a report.** While a suspected relationship *may* exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product."
-- "Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. In recent years the FDA has undertaken efforts to increase collection of adverse events. Increases in the total number of adverse events is likely caused by improved reporting."
-- "### How adverse events are organized"
-- "Adverse events are collected through a series of *safety reports.* Each is identified by a 8-digit string (for instance, `6176304-1`). The first 7 digits (before the hyphen) identify the individual report, and the last digit (after the hyphen) is a checksum. Rather than updating individual records in FAERS, subsequent updates are submitted in seperate reports."
-- "### Format"
-- "Adverse event reports use the [ICH E2b/M2 version 2.1 standard.](http://estri.ich.org/e2br22/ICH_ICSR_Specification_V2-3.pdf) OpenFDA annotates the original records with [special fields.](#openfda-fields)"
-- "### Downloads"
-- "downloads"
-- "FDA releases quarterly updates to FAERS data. OpenFDA uses these extracts, but processes the data further before supplying them through the API. There are no plans for the openFDA initiative to change the FAERS release protocols. At this time it is anticipated that FAERS downloads will continue to be available from the same site on the same quarterly schedule. OpenFDA is a research project to make access to these datasets easier, not replace the current process. The information available through openFDA is not for clinical production use. While FDA makes every effort to ensure the data is accurate, it should be assumed that all results are not validated."
-- "### Results"
-- "For non-`count` queries, the `results` section includes matching adverse event reports returned by the API."
-- "Each adverse event report consists of these major sections:"
-- ul:
- - "**Header:** General information about the adverse event"
- - "**Patient Information:** Details on the patient who experienced the event, such as age, weight, sex, etc."
- - "**Drugs:** Information on the drugs taken while the event was experienced"
- - "**Reactions:** Information on the reactions experienced by the patient"
-- "## Field-by-field reference"
-- "### Header"
-- "General information about the adverse event."
-- example: header
-- fields:
- - safetyreportid
- - safetyreportversion
- - receivedate
- - receivedateformat
- - receiptdate
- - receiptdateformat
- - serious
- - seriousnessdeath
- - seriousnessdisabling
- - seriousnesshospitalization
- - seriousnesslifethreatening
- - seriousnessother
- - transmissiondate
- - transmissiondateformat
- - duplicate
- - companynumb
- - occurcountry
- - primarysourcecountry
- - primarysource
- - primarysource.qualification
- - primarysource.reportercountry
- - reportduplicate
- - reportduplicate.duplicatesource
- - reportduplicate.duplicatenumb
- - sender
- - sender
- - sender.sendertype
- - sender.senderorganization
- - receiver
-- "### Patient"
-- "Information about the patient in the adverse event report."
-- example: patient
-- fields:
- - patient.patientonsetage
- - patient.patientonsetageunit
- - patient.patientsex
- - patient.patientweight
- - patient.patientdeath
- - patient.patientdeath.patientdeathdate
- - patient.patientdeath.patientdeathdateformat
-- "#### Drugs"
-- "This section contains information about the drugs listed in the adverse event report."
-- fields:
- - patient.drug.actiondrug
- - patient.drug.drugadditional
- - patient.drug.drugcumulativedosagenumb
- - patient.drug.drugcumulativedosageunit
- - patient.drug.drugdosageform
- - patient.drug.drugintervaldosagedefinition
- - patient.drug.drugintervaldosageunitnumb
- - patient.drug.drugrecurreadministration
- - patient.drug.drugseparatedosagenumb
- - patient.drug.drugstructuredosagenumb
- - patient.drug.drugstructuredosageunit
- - patient.drug.drugadministrationroute
- - patient.drug.drugauthorizationnumb
- - patient.drug.drugbatchnumb
- - patient.drug.drugcharacterization
- - patient.drug.drugdosagetext
- - patient.drug.drugenddate
- - patient.drug.drugenddateformat
- - patient.drug.drugindication
- - patient.drug.drugstartdate
- - patient.drug.drugstartdateformat
- - patient.drug.drugtreatmentduration
- - patient.drug.drugtreatmentdurationunit
- - patient.drug.medicinalproduct
-- "#### OpenFDA fields"
-- "Different datasets use different drug identifiers—brand name, generic name, NDA, NDC, etc. It can be difficult to find the same drug in different datasets. And some identifiers, like pharmacologic class, are useful search filters but not available in all datasets."
-- "OpenFDA features harmonization of drug identifiers, to make it easier to connect adverse event report records to other drug information. Drug products that appear in FAERS records are joined to the NDC dataset first on brand name, and if there is no brand name, on generic name. If that is succesful, further links are established to other datasets. The linked data is listed as an `openfda` annotation in the `patient.drug` section of a result."
-- "Roughly 86% of adverse event records have at least one `openfda` section. Because the harmonization process requires an exact match, some drug products cannot be harmonized in this fashion—for instance, if the drug name is misspelled. Some drug products will have `openfda` sections, while others will never, if there was no match during the harmonization process."
-- fields:
- - patient.drug.openfda
-- disclaimer:
- - "A single drug product listed in an adverse event report may have multiple associated manufacturer names, NDCs, and SPLs in a corresponding `openfda` section. That is because the drug may have multiple manufacturers, packagers, dosage forms, etc. Their inclusion in the `openfda` section does not mean that they had any connection to the adverse event. The ordering of data in `openfda` fields is not significant."
-- "#### Reactions"
-- fields:
- - patient.reaction.reactionmeddrapt
- - patient.reaction.reactionmeddraversionpt
- - patient.reaction.reactionoutcome
-- "datasets"
-
diff --git a/pages/api_endpoints/drug/event/_examples.json b/pages/api_endpoints/drug/event/_examples.json
deleted file mode 100644
index 964e3ee1..00000000
--- a/pages/api_endpoints/drug/event/_examples.json
+++ /dev/null
@@ -1,134 +0,0 @@
-{
- "header": {
- "safetyreport": "1234567-8",
- "safetyreportversion": "17",
- "receivedate": "20041025",
- "receivedateformat": "102",
- "receiptdate": "20040224",
- "receiptdateformat": "102",
- "serious": "1",
- "seriousnesscongenitalanomali": "1",
- "seriousnessdeath": "1",
- "seriousnessdisabling": "1",
- "seriousnesshospitalization": "1",
- "seriousnesslifethreatening": "1",
- "seriousnessother": "1",
- "transmissiondate": "1",
- "transmissiondateformat": "1",
- "duplicate": "1",
- "companynumb": "200501050",
- "occurcountry": "US",
- "primarysourcecountry": "US",
- "primarysource": {
- "qualification": "1",
- "reportercountry": "UNITED STATES"
- },
- "reportduplicate": {
- "duplicatesource": "NOVARTIS",
- "duplicatenumb": "PHEH2006US00792"
- },
- "sender": {
- "sendertype": "2",
- "senderorganization": "FDA-Public Use"
- },
- "receiver": {
- "receivertype": "6",
- "receiverorganization": "FDA"
- }
- },
- "patient": {
- "patientonsetage": "59",
- "patientonsetageunit": "801",
- "patientsex": "2",
- "patientweight": "78",
- "patientdeath": {
- "patientdeathdate": "20030401",
- "patientdeathdateformat": "102"
- },
- "drug": [
- {
- "actiondrug": "1",
- "drugadditional": "1",
- "drugcumulativedosagenumb": "4100",
- "drugcumulativedosageunit": "003",
- "drugdosageform": "Tablet",
- "drugintervaldosagedefinition": "804",
- "drugintervaldosageunitnumb": "1",
- "drugrecurreadministration": "3",
- "drugseparatedosagenumb": "1",
- "drugstructuredosagenumb": "600",
- "drugstructuredosageunit": "003",
- "drugadministrationroute": "048",
- "drugauthorizationnumb": "021223",
- "drugbatchnumb": "020113A",
- "drugcharacterization": "1",
- "drugdoseagetext": "3.5 MG/KG, 1 IN 1 AS NECESSARY, INTRAVENOUS DRIP",
- "drugenddate": "20020920",
- "drugenddateformat": "102",
- "drugindication": "RHEUMATOID ARTHRITIS",
- "drugstartdate": "20020903",
- "drugstartdateformat": "102",
- "drugtreatmentduration": "1",
- "drugtreatmentdurationunit": "804",
- "medicinalproduct": "ASCORBIC ACID",
- "openfda": {
- "spl_id": [
- "f67ce1df-27ea-4c67-a8a3-daf3fb3b9a92",
- "72133842-ac3f-4a39-a825-38e01930a0a7"
- ],
- "product_ndc": [
- "0389-0486",
- "67457-118",
- "67457-303"
- ],
- "route": [
- "INTRAMUSCULAR",
- "INTRAVENOUS",
- "SUBCUTANEOUS"
- ],
- "substance_name": [
- "ASCORBIC ACID"
- ],
- "rxcui": [
- "308395"
- ],
- "spl_set_id": [
- "a6c36a36-28ee-4a1b-86fe-98ef94064b68",
- "d05200cb-cf29-4bc7-bf0c-b42ab2d20958"
- ],
- "package_ndc": [
- "67457-118-50",
- "0389-0486-50",
- "67457-303-50"
- ],
- "product_type": [
- "HUMAN PRESCRIPTION DRUG"
- ],
- "generic_name": [
- "ASCORBIC ACID"
- ],
- "manufacturer_name": [
- "The Torrance Company",
- "Mylan Institutional LLC"
- ],
- "brand_name": [
- "ASCORBIC ACID"
- ]
- }
- }
- ],
- "reaction": [
- {
- "reactionmeddrapt": "Osteonecrosis of jaw",
- "reactionmeddraversionpt": "16.1",
- "reactionoutcome": "6"
- },
- {
- "reactionmeddrapt": "HYPERTENSION"
- },
- {
- "reactionmeddrapt": "POLYTRAUMATISM"
- }
- ]
- }
-}
diff --git a/pages/api_endpoints/drug/event/_explorers.yaml b/pages/api_endpoints/drug/event/_explorers.yaml
deleted file mode 100644
index f58f16ff..00000000
--- a/pages/api_endpoints/drug/event/_explorers.yaml
+++ /dev/null
@@ -1,29 +0,0 @@
-oneReport:
- title: One adverse event report
- description:
- - This query searches for all records in a certain date range, and asks for a single one. See the header fields reference for more about receivedate. Brackets `[ ]` are used to specify a range for date, number, or string fields.
- - See the [header fields reference](/drug/event/reference/) for more about receivedate. Brackets `[ ]` are used to specify a range for date, number, or string fields.
- params:
- - search for all records with receivedate between Jan 01, 2004 and Dec 31, 2008. limit to 1 record.
- - see the header fields reference for more about receivedate. Brackets [ ] are used to specify a range for date, number, or string fields.
- query: 'https://api.fda.gov/drug/event.json?search=receivedate:[20040101+TO+20081231]&limit=1'
-pharmacologic:
- title: One adverse event report with a drug from a certain pharmacologic class
- description:
- - 'This query searches records listing a drug of a certain pharmacologic class, and returns a single record. A record returned by this query may have multiple drugs listed. At least one of the drugs belongs to the pharmacologic class. See the openFDA fields reference for more about the kinds of searches they enable. Double quotation marks `" "` surround phrases that must match exactly. The plus sign + is used in place of a space character ` `.'
- - A record returned by this query may have multiple drugs listed. At least one of the drugs belongs to the pharmacologic class. See the [openFDA fields reference](/drug/event/reference/) for more about the kinds of searches they enable.
- - 'Double quotation marks `" "` surround phrases that must match exactly. The plus sign + is used in place of a space character.'
- params:
- - search for all records with receivedate between Jan 01, 2004 and Dec 31, 2008. limit to 1 record.
- - see the header fields reference for more about receivedate. Brackets [ ] are used to specify a range for date, number, or string fields.
- query: 'https://api.fda.gov/drug/event.json?search=patient.drug.openfda.pharm_class_epc:"nonsteroidal+anti-inflammatory+drug"&limit=1'
-reaction:
- title: Count of patient reactions
- description:
- - This query is similar to the prior one, but returns a count of the 1000 most frequently reported patient reactions. Multiple drugs in the records may match this class, and the drugs from this class may not be those which caused the associated adverse patient reactions. The suffix .exact is required by openFDA to count the unique full phrases in the field patient.reaction.reactionmeddrapt. Without it, the API will count each word in that field individually—difficulty sleeping would be counted as separate values, difficulty and sleeping. See the patient reaction reference for more about patient reactions in adverse event records.
- - The suffix .exact is required by openFDA to count the unique full phrases in the field patient.reaction.reactionmeddrapt. Without it, the API will count each word in that field individually—difficulty sleeping would be counted as separate values, difficulty and sleeping.
- - See the [patient reaction reference](/drug/event/reference/) for more about patient reactions in adverse event records.
- params:
- - search for all records with receivedate between Jan 01, 2004 and Dec 31, 2008. limit to 1 record.
- - see the header fields reference for more about receivedate. Brackets `[ ]` are used to specify a range for date, number, or string fields.
- query: 'https://api.fda.gov/drug/event.json?search=patient.drug.openfda.pharm_class_epc:"nonsteroidal+anti-inflammatory+drug"&count=patient.reaction.reactionmeddrapt.exact'
diff --git a/pages/api_endpoints/drug/event/_fields.yaml b/pages/api_endpoints/drug/event/_fields.yaml
deleted file mode 100644
index c5eb85ec..00000000
--- a/pages/api_endpoints/drug/event/_fields.yaml
+++ /dev/null
@@ -1,892 +0,0 @@
-type: object
-properties:
- authoritynumb:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Populated with the Regulatory Authority’s case report number, when available."
- possible_values:
- companynumb:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Identifier for the company providing the report. This is self-assigned."
- possible_values:
- duplicate:
- format:
- is_exact: false
- type: string
- pattern:
- description: "This value is `1` if earlier versions of this report were submitted to FDA. openFDA only shows the most recent version."
- possible_values:
- fulfillexpeditecriteria:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "Identifies expedited reports (those that were processed within 15 days)."
- possible_values:
- type: one_of
- value:
- '1': Yes
- '2': No
- occurcountry:
- format:
- is_exact: true
- type: string
- pattern: ^[A-Z]{2}$
- description: "The name of the country where the event occurred."
- possible_values:
- type: reference
- value:
- name: "Country codes"
- link: "http://data.okfn.org/data/core/country-list"
- patient:
- type: object
- properties:
- drug:
- type: array
- items:
- properties:
- actiondrug:
- format: int64
- is_exact: false
- type: string
- pattern:
- description: "Actions taken with the drug."
- possible_values:
- type: one_of
- value:
- '1': "Drug withdrawn"
- '2': "Dose reduced"
- '3': "Dose increased"
- '4': "Dose not changed"
- '5': "Unknown"
- '6': "Not applicable"
- activesubstance:
- type: object
- properties:
- activesubstancename:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Product active ingredient, which may be different than other drug identifiers (when provided)."
- possible_values:
- drugadditional:
- format: int64
- is_exact: false
- type: string
- pattern:
- description: "Dechallenge outcome information—whether the event abated after product use stopped or the dose was reduced. Only present when this was attempted and the data was provided."
- possible_values:
- type: one_of
- value:
- '1': 'Yes'
- '2': 'No'
- '3': 'Does not apply'
- drugadministrationroute:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The drug’s route of administration."
- possible_values:
- type: one_of
- value:
- '001': "Auricular (otic)"
- '002': "Buccal"
- '003': "Cutaneous"
- '004': "Dental"
- '005': "Endocervical"
- '006': "Endosinusial"
- '007': "Endotracheal"
- '008': "Epidural"
- '009': "Extra-amniotic"
- '010': "Hemodialysis"
- '011': "Intra corpus cavernosum"
- '012': "Intra-amniotic"
- '013': "Intra-arterial"
- '014': "Intra-articular"
- '015': "Intra-uterine"
- '016': "Intracardiac"
- '017': "Intracavernous"
- '018': "Intracerebral"
- '019': "Intracervical"
- '020': "Intracisternal"
- '021': "Intracorneal"
- '022': "Intracoronary"
- '023': "Intradermal"
- '024': "Intradiscal (intraspinal)"
- '025': "Intrahepatic"
- '026': "Intralesional"
- '027': "Intralymphatic"
- '028': "Intramedullar (bone marrow)"
- '029': "Intrameningeal"
- '030': "Intramuscular"
- '031': "Intraocular"
- '032': "Intrapericardial"
- '033': "Intraperitoneal"
- '034': "Intrapleural"
- '035': "Intrasynovial"
- '036': "Intratumor"
- '037': "Intrathecal"
- '038': "Intrathoracic"
- '039': "Intratracheal"
- '040': "Intravenous bolus"
- '041': "Intravenous drip"
- '042': "Intravenous (not otherwise specified)"
- '043': "Intravesical"
- '044': "Iontophoresis"
- '045': "Nasal"
- '046': "Occlusive dressing technique"
- '047': "Ophthalmic"
- '048': "Oral"
- '049': "Oropharingeal"
- '050': "Other"
- '051': "Parenteral"
- '052': "Periarticular"
- '053': "Perineural"
- '054': "Rectal"
- '055': "Respiratory (inhalation)"
- '056': "Retrobulbar"
- '057': "Sunconjunctival"
- '058': "Subcutaneous"
- '059': "Subdermal"
- '060': "Sublingual"
- '061': "Topical"
- '062': "Transdermal"
- '063': "Transmammary"
- '064': "Transplacental"
- '065': "Unknown"
- '066': "Urethral"
- '067': "Vaginal"
- drugauthorizationnumb:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{6}$
- description: "Drug authorization or application number (NDA or ANDA), if provided."
- possible_values:
- drugbatchnumb:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Drug product lot number, if provided."
- possible_values:
- drugcharacterization:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "Reported role of the drug in the adverse event report. These values are not validated by FDA."
- possible_values:
- type: one_of
- value:
- '1': "Suspect (the drug was considered by the reporter to be the cause)"
- '2': "Concomitant (the drug was reported as being taken along with the suspect drug)"
- '3': "Interacting (the drug was considered by the reporter to have interacted with the suspect drug)"
- drugcumulativedosagenumb:
- format: float
- is_exact: false
- type: string
- pattern:
- description: "The cumulative dose taken until the first reaction was experienced, if provided."
- possible_values:
- drugcumulativedosageunit:
- format:
- is_exact: false
- type: string
- pattern:
- description: "The unit for `drugcumulativedosagenumb`."
- possible_values:
- type: one_of
- value:
- "001": "kg (kilograms)"
- "002": "g (grams)"
- "003": "mg (milligrams)"
- "004": "µg (micrograms)"
- drugdosageform:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The drug’s dosage form. There is no standard, but values may include terms like `tablet` or `solution for injection`."
- possible_values:
- drugdosagetext:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Additional detail about the dosage taken. Frequently unknown, but occasionally including information like a brief textual description of the schedule of administration."
- possible_values:
- drugenddate:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "Date the patient stopped taking the drug."
- possible_values:
- drugenddateformat:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Encoding format of the field `drugenddateformat`. Always set to `102` (YYYYMMDD)."
- possible_values:
- drugindication:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Indication for the drug’s use."
- possible_values:
- drugintervaldosagedefinition:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "The unit for the interval in the field `drugintervaldosageunitnumb.`"
- possible_values:
- type: one_of
- value:
- '801': "Year"
- '802': "Month"
- '803': "Week"
- '804': "Day"
- '805': "Hour"
- '806': "Minute"
- '807': "Trimester"
- '810': "Cyclical"
- '811': "Trimester"
- '812': "As necessary"
- '813': "Total"
- drugintervaldosageunitnumb:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "Number of units in the field `drugintervaldosagedefinition`."
- possible_values:
- drugrecurreadministration:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "Whether the reaction occured after readministration of the drug."
- possible_values:
- type: one_of
- value:
- '1': "Yes"
- '2': "No"
- '3': "Unknown"
- drugrecurrence:
- properties:
- drugrecuraction:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Populated with the Reaction/Event information if/when `drugrecurreadministration` equals `1`."
- possible_values:
- drugseparatedosagenumb:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "The number of separate doses that were administered."
- possible_values:
- drugstartdate:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "Date the patient began taking the drug."
- possible_values:
- drugstartdateformat:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Encoding format of the field `drugstartdate`. Always set to `102` (YYYYMMDD)."
- possible_values:
- drugstructuredosagenumb:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The number portion of a dosage; when combined with `drugstructuredosageunit` the complete dosage information is represented. For example, *300* in `300 mg`."
- possible_values:
- drugstructuredosageunit:
- format:
- is_exact: false
- type: string
- pattern:
- description: "The unit for the field `drugstructuredosagenumb`. For example, *mg* in `300 mg`."
- possible_values:
- type: one_of
- value:
- '001': "kg (kilograms)"
- '002': "g (grams)"
- '003': "mg (milligrams)"
- '004': "µg (micrograms)"
- drugtreatmentduration:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The interval of the field `drugtreatmentdurationunit` for which the patient was taking the drug."
- possible_values:
- drugtreatmentdurationunit:
- format:
- is_exact: false
- type: string
- pattern:
- description:
- possible_values:
- type: one_of
- value:
- '801': "Year"
- '802': "Month"
- '803': "Week"
- '804': "Day"
- '805': "Hour"
- '806': "Minute"
- medicinalproduct:
- format:
- type: string
- pattern:
- is_exact: true
- description: "Drug name. This may be the valid trade name of the product (such as `ADVIL` or `ALEVE`) or the generic name (such as `IBUPROFEN`). This field is not systematically normalized. It may contain misspellings or idiosyncratic descriptions of drugs, such as combination products such as those used for birth control."
- possible_values:
- openfda:
- type: object
- properties:
- application_number:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[BLA|ANDA|NDA]{3,4}[0-9]{6}$
- description: "This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null."
- possible_values:
- brand_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Brand or trade name of the drug product."
- possible_values:
- generic_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Generic name(s) of the drug product."
- possible_values:
- manufacturer_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC."
- possible_values:
- nui:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[N][0-9]{10}$
- description: "Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT)."
- possible_values:
- type: reference
- value:
- name: "NDF-RT"
- link: "https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NDFRT/"
- package_ndc:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{5,4}-[0-9]{4,3}-[0-9]{1,2}$
- description: "This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug."
- possible_values:
- pharm_class_cs:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]."
- possible_values:
- pharm_class_epc:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`."
- possible_values:
- pharm_class_pe:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`."
- possible_values:
- pharm_class_moa:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`."
- possible_values:
- product_ndc:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{5,4}-[0-9]{4,3}$
- description: "The labeler manufacturer code and product code segments of the NDC number, separated by a hyphen."
- possible_values:
- product_type:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description:
- possible_values:
- type: reference
- value:
- name: "Type of drug product"
- link: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162063.htm
- route:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The route of administation of the drug product."
- possible_values:
- type: reference
- value:
- name: "Route of administration"
- link: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162034.htm
- rxcui:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{6}$
- description: "The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms."
- possible_values:
- type: reference
- value:
- name: "RxNorm and RxCUI documentation"
- link: "https://www.nlm.nih.gov/research/umls/rxnorm/docs/2012/rxnorm_doco_full_2012-3.html"
- spl_id:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$
- description: "Unique identifier for a particular version of a Structured Product Label for a product. Also referred to as the document ID."
- possible_values:
- spl_set_id:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$
- description: "Unique identifier for the Structured Product Label for a product, which is stable across versions of the label. Also referred to as the set ID."
- possible_values:
- substance_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The list of active ingredients of a drug product."
- possible_values:
- unii:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[A-Z0-9]{10}$
- description: "Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information."
- possible_values:
- type: reference
- value:
- name: "Unique Ingredient Identifiers"
- link: "http://fdasis.nlm.nih.gov/srs/srs.jsp"
- patientagegroup:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "Populated with Patient Age Group code."
- possible_values:
- type: one_of
- value:
- '1': "Neonate"
- '2': "Infant"
- '3': "Child"
- '4': "Adolescent"
- '5': "Adult"
- '6': "Elderly"
- patientdeath:
- type: object
- properties:
- patientdeathdate:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "If the patient died, the date that the patient died."
- possible_values:
- patientdeathdateformat:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Encoding format of the field `patientdeathdate`. Always set to `102` (YYYYMMDD)."
- possible_values:
- patientonsetage:
- format: float
- is_exact: false
- type: string
- pattern:
- description: "Age of the patient when the event first occured."
- possible_values:
- patientonsetageunit:
- format:
- is_exact: false
- type: string
- pattern:
- description: "The unit for the interval in the field `patientonsetage.`"
- possible_values:
- type: one_of
- value:
- '800': "Decade"
- '801': "Year"
- '802': "Month"
- '803': "Week"
- '804': "Day"
- '805': "Hour"
- patientsex:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "The sex of the patient."
- possible_values:
- type: one_of
- value:
- '0': "Unknown"
- '1': "Male"
- '2': "Female"
- patientweight:
- format: float
- is_exact: false
- type: string
- pattern:
- description: "The patient weight, in kg (kilograms)."
- possible_values:
- reaction:
- type: array
- items:
- type: object
- properties:
- reactionmeddrapt:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Patient reaction, as a MedDRA term. Note that these terms are encoded in British English. For instance, diarrhea is spelled `diarrohea`. MedDRA is a standardized medical terminology."
- possible_values:
- type: reference
- value:
- name: "MedDRA"
- link: "http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm"
- reactionmeddraversionpt:
- format:
- is_exact: false
- type: string
- pattern:
- description: "The version of MedDRA from which the term in `reactionmeddrapt` is drawn."
- possible_values:
- reactionoutcome:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "Outcome of the reaction in `reactionmeddrapt` at the time of last observation."
- possible_values:
- type: one_of
- value:
- '1': "Recovered/resolved"
- '2': "Recovering/resolving"
- '3': "Not recovered/not resolved"
- '4': "Recovered/resolved with sequelae (consequent health issues)"
- '5': "Fatal"
- '6': "Unknown"
- summary:
- type: object
- properties:
- narrativeincludeclinical:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Populated with Case Event Date, when available; does `NOT` include Case Narrative."
- possible_values:
- primarysource:
- type: object
- properties:
- literaturereference:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Populated with the Literature Reference information, when available."
- possible_values:
- qualification:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Category of individual who submitted the report."
- possible_values:
- type: one_of
- value:
- '1': "Physician"
- '2': "Pharmacist"
- '3': "Other health professional"
- '4': "Lawyer"
- '5': "Consumer or non-health professional"
- reportercountry:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Country from which the report was submitted."
- possible_values:
- primarysourcecountry:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Country of the reporter of the event."
- possible_values:
- type: reference
- value:
- name: "Country codes"
- link: "http://data.okfn.org/data/core/country-list"
- receiptdate:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "Date that the _most recent_ information in the report was received by FDA."
- possible_values:
- receiptdateformat:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Encoding format of the `transmissiondate` field. Always set to 102 (YYYYMMDD)."
- possible_values:
- receivedate:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "Date that the report was _first_ received by FDA. If this report has multiple versions, this will be the date the first version was received by FDA."
- possible_values:
- receivedateformat:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Encoding format of the `transmissiondate` field. Always set to 102 (YYYYMMDD)."
- possible_values:
- receiver:
- description: "Information on the organization receiving the report."
- properties:
- receiverorganization:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Name of the organization receiving the report. Because FDA received the report, the value is always `FDA`."
- possible_values:
- receivertype:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "The type of organization receiving the report. The value,`6`, is only specified if it is `other`, otherwise it is left blank."
- possible_values:
- type: one_of
- value:
- '6': "Other"
- reportduplicate:
- type: object
- description: "If a report is a duplicate or more recent version than a previously submitted report, this field will provide additional details on source provider."
- properties:
- duplicatenumb:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The case identifier for the duplicate."
- possible_values:
- duplicatesource:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The name of the organization providing the duplicate."
- possible_values:
- reporttype:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "Code indicating the circumstances under which the report was generated."
- possible_values:
- type: one_of
- value:
- '1': "Spontaneous"
- '2': "Report from study"
- '3': "Other"
- '4': "Not available to sender (unknown)"
- safetyreportid:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{7}-[0-9]{1,2}$
- description: "The 8-digit Safety Report ID number, also known as the case report number or case ID. The first 7 digits (before the hyphen) identify an individual report and the last digit (after the hyphen) is a checksum. This field can be used to identify or find a specific adverse event report."
- possible_values:
- safetyreportversion:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "The version number of the `safetyreportid`. Multiple versions of the same report may exist, it is generally best to only count the latest report and disregard others. openFDA will only return the latest version of a report."
- possible_values:
- sender:
- type: object
- properties:
- senderorganization:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Name of the organization sending the report. Because FDA is providing these reports to you, the value is always `FDA-Public Use.`"
- possible_values:
- sendertype:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "The name of the organization sending the report. Because FDA is providing these reports to you, the value is always `2`."
- possible_values:
- type: one_of
- value:
- '2': "Regulatory authority"
- serious:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "Seriousness of the adverse event."
- possible_values:
- type: one_of
- value:
- '1': "The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition"
- '2': "The adverse event did not result in any of the above"
- seriousnesscongenitalanomali:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "This value is `1` if the adverse event resulted in a congenital anomaly, and absent otherwise."
- possible_values:
- seriousnessdeath:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "This value is `1` if the adverse event resulted in death, and absent otherwise."
- possible_values:
- seriousnessdisabling:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "This value is `1` if the adverse event resulted in disability, and absent otherwise."
- possible_values:
- seriousnesshospitalization:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "This value is `1` if the adverse event resulted in a hospitalization, and absent otherwise."
- possible_values:
- seriousnesslifethreatening:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "This value is `1` if the adverse event resulted in a life threatening condition, and absent otherwise."
- possible_values:
- seriousnessother:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "This value is `1` if the adverse event resulted in some other serious condition, and absent otherwise."
- possible_values:
- transmissiondate:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "Date that the record was created. This may be earlier than the date the record was received by the FDA."
- possible_values:
- transmissiondateformat:
- format: int32
- is_exact: false
- type: string
- pattern:
- description: "Encoding format of the `transmissiondate` field. Always set to 102 (YYYYMMDD)."
- possible_values:
diff --git a/pages/api_endpoints/drug/event/_infographics.yaml b/pages/api_endpoints/drug/event/_infographics.yaml
deleted file mode 100644
index 4f7c3df3..00000000
--- a/pages/api_endpoints/drug/event/_infographics.yaml
+++ /dev/null
@@ -1,94 +0,0 @@
-- title: "Adverse drug event reports since 2004"
- short: "Reports over time"
- description:
- - "This is the openFDA API endpoint for adverse drug events. An adverse event is submitted to the FDA to report any undesirable experience associated with the use of a drug, including serious drug side effects, product use errors, product quality problems, and therapeutic failures."
- - "Reporting of adverse events by healthcare professionals and consumers is voluntary in the United States. Increases in the total number of adverse events are likely caused by improved reporting. News, enforcement actions, and other phenomena can also spur reporting."
- countParam: "receivedate"
- filters:
- - title: "All adverse event reports"
- searchParam: ""
- - title: "Reported through manufacturers"
- searchParam: "_exists_:companynumb"
- - title: "Reported directly by public"
- searchParam: "_missing_:companynumb"
- - title: "Where indication for drug use was hypertension"
- searchParam: "patient.drug.drugindication:hypertension"
- dateConstraint: receivedate
- type: Line
-- title: "Who reports adverse events?"
- short: "Who reports?"
- description:
- - "The vast majority of adverse event reports are ultimately reported to FDA through drug product manufacturers. But those reports may first be initiated by consumers, health professionals, or others."
- countParam: "primarysource.qualification"
- filters:
- - title: "All adverse event reports"
- searchParam: ""
- - title: "Reported through manufacturers"
- searchParam: "_exists_:companynumb"
- - title: "Reported directly by public"
- searchParam: "_missing_:companynumb"
- dateConstraint: receivedate
- type: Pie
-- title: "What classes of drugs are reported?"
- short: "Drug classes"
- description:
- - "The seriousness of reported adverse events varies with the associated drugs. This chart shows the drug classes most often associated with adverse event reports. Use the buttons next to the chart to see the difference between reports involving serious reactions and less serious reactions."
- countParam: "patient.drug.openfda.pharm_class_epc.exact"
- filters:
- - title: "All adverse event reports"
- searchParam: ""
- - title: "Serious Reactions"
- searchParam: "serious:1"
- - title: "Less serious reactions"
- searchParam: "serious:2"
- dateConstraint: receivedate
- type: Bar
-- title: "What indications for use are frequently reported?"
- short: "Drug indications"
- description:
- - "Drugs listed in adverse event reports often have an indication for use specified—a disease being treated, or a certain therapeutic goal. Use the buttons next to the chart to see how indications for use change with different search criteria."
- countParam: "patient.drug.drugindication.exact"
- filters:
- - title: "All"
- searchParam: ""
- - title: "Nonsteroidal anti-inflammatory drug class"
- searchParam: 'patient.drug.openfda.pharm_class_epc:"nonsteroidal+anti-inflammatory+drug"'
- - title: "Females"
- searchParam: "patient.patientsex:2"
- - title: "Females, age 5 to 17"
- searchParam: "patient.patientsex:2+AND+patient.patientonsetage:[5+TO+17]"
- - title: "Females, age 55 to 90"
- searchParam: "patient.patientsex:2+AND+patient.patientonsetage:[55+TO+90]"
- - title: "Males"
- searchParam: "patient.patientsex:1"
- - title: "Males, age 5 to 17"
- searchParam: "patient.patientsex:1+AND+patient.patientonsetage:[5+TO+17]"
- - title: "Males, age 55 to 90"
- searchParam: "patient.patientsex:1+AND+patient.patientonsetage:[55+TO+90]"
- dateConstraint: receivedate
- type: Bar
-- title: "What adverse reactions are frequently reported?"
- short: "Drug reactions"
- description:
- - "Adverse reactions range from product quality issues to very serious outcomes, including death. Use the buttons next to the chart to see how reported reactions vary with different search criteria."
- - "There is no certainty that a reported event (adverse reaction or medication error) was actually due to a product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event."
- countParam: "patient.reaction.reactionmeddrapt.exact"
- filters:
- - title: "All"
- searchParam: ""
- - title: "Nonsteroidal anti-inflammatory drug class"
- searchParam: 'patient.drug.openfda.pharm_class_epc:"nonsteroidal+anti-inflammatory+drug"'
- - title: "Females"
- searchParam: "patient.patientsex:2"
- - title: "Females, age 5 to 17"
- searchParam: "patient.patientsex:2+AND+patient.patientonsetage:[5+TO+17]"
- - title: "Females, age 55 to 90"
- searchParam: "patient.patientsex:2+AND+patient.patientonsetage:[55+TO+90]"
- - title: "Males"
- searchParam: "patient.patientsex:1"
- - title: "Males, age 5 to 17"
- searchParam: "patient.patientsex:1+AND+patient.patientonsetage:[5+TO+17]"
- - title: "Males, age 55 to 90"
- searchParam: "patient.patientsex:1+AND+patient.patientonsetage:[55+TO+90]"
- dateConstraint: receivedate
- type: Bar
diff --git a/pages/api_endpoints/drug/event/_meta.yaml b/pages/api_endpoints/drug/event/_meta.yaml
deleted file mode 100644
index 7cac1eb9..00000000
--- a/pages/api_endpoints/drug/event/_meta.yaml
+++ /dev/null
@@ -1,12 +0,0 @@
-documentTitle: openFDA › Drugs › Adverse events API
-label: Drug adverse events
-title: Drug Adverse Events
-description: "An adverse event is submitted to the FDA to report any undesirable experience associated with the use of a drug, including serious drug side effects, product use errors, product quality problems, and therapeutic failures."
-datasets:
- - FAERS
-path: /api_endpoints/drug/event
-api_path: /drug/event
-start: 20040101
-status: drugevent
-dateConstraintKey: receivedate
-type: endpoint
\ No newline at end of file
diff --git a/pages/api_endpoints/drug/event/index.jsx b/pages/api_endpoints/drug/event/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/drug/event/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/drug/index.jsx b/pages/api_endpoints/drug/index.jsx
deleted file mode 100644
index a9fabe2f..00000000
--- a/pages/api_endpoints/drug/index.jsx
+++ /dev/null
@@ -1,33 +0,0 @@
-import React from 'react'
-import Layout from '../../../components/Layout'
-import Hero from '../../../components/Hero'
-import EndpointBox from '../../../components/EndpointBox'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-
-
-
Drug API Endpoints
-
-
-
-
-
-
-
-)
diff --git a/pages/api_endpoints/drug/label/_content.yaml b/pages/api_endpoints/drug/label/_content.yaml
deleted file mode 100644
index 24bd3c25..00000000
--- a/pages/api_endpoints/drug/label/_content.yaml
+++ /dev/null
@@ -1,155 +0,0 @@
-- "## About drug product labeling"
-- Drug manufacturers and distributors submit documentation about their products to FDA in the [Structured Product Labeling (SPL) format](http://labels.fda.gov/). The labeling is a "living document" that changes over time to reflect increased knowledge about the safety and effectiveness of the drug.
-- The openFDA drug product labels API returns data from these submissions for both prescription and over-the-counter (OTC) drugs. The labels are broken into sections, such as indications for use (prescription drugs) or purpose (OTC drugs), adverse reactions, and so forth. There is considerable variation between drug products in terms of these sections and their contents, since the information required for safe and effective use varies with the unique characteristics of each drug product.
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/drug/label.json` using search parameters for fields specific to the drug labeling endpoint."
-- queryExplorer: oneLabel
-- queryExplorer: boxedWarning
-- queryExplorer: countByType
-- "## Data reference"
-- "Note that the effective_time of labeling is used to calculate how current data is. Some labeling is dated in the future, and that is reflected in the calculation above."
-- "The openFDA drug product labeling API returns data from the [FDA Structured Product Labeling](/data/spl/) (SPL) dataset. This dataset contains structured documentation about regulated products, submitted by manufacturers to FDA. OpenFDA uses the latest available bulk downloads, which have the latest version of every structured product labeling document for products that are actively marketed."
-- "### What is structured product labeling?"
-- Drug manufacturers and distributors submit documentation about their products to FDA. Labeling contains a summary of the essential scientific information needed for the safe and effective use of the drug.
-- The openFDA drug product labeling API returns data from these submissions for both prescription and over-the-counter (OTC) drugs. The labeling is broken into sections, such as indications for use (prescription drugs) or purpose (OTC drugs), adverse reactions, and so forth. There is considerable variation between drug products, since the information required for safe and effective use varies with the unique characteristics of each drug product.
-- "### Downloads"
-- "downloads"
-- "## Anatomy of a response"
-- "This is a simulated openFDA API return for a non-`count` query. It is divided into two high-level sections, `meta` and `results`."
-- example: anatomy
-- "### Meta"
-- "For non-`count` queries, the `meta` section includes a disclaimer, a link to the openFDA data license, and information about the results that follow."
-- example: meta
-- fields:
- - meta.disclaimer
- - meta.license
- - meta.last_updated
- - meta.results.skip
- - meta.results.limit
- - meta.results.total
-- "### Results"
-- "For non-`count` queries, the `results` section includes matching adverse event reports returned by the API."
-- "Each SPL record consists of three sets of fields:"
-- ul:
- - "Standard SPL fields, including unique identifiers."
- - "Product-specific fields, the order and contents of which are unique to each product."
- - "An **openFDA** section: An annotation with additional product identifiers, such as UPC and brand name, of the drug products listed in the labeling."
-- "#### Field variation"
-- Fields vary with the particular product being documented. Some fields are rarely used. Most prescription drug product labeling will feature similar fields, and those fields will contain similar content. Over-the-counter (OTC) drug product labeling will generally feature a different set of fields.
-- The specific requirements for content of these fields vary from product to product. General descriptions of the fields are provided below, along with notable exceptions or exceptional cases. Expect variation.
-- FDA regulations describe these fields more thoroughly than this documentation. The following documents may be useful for more information about [prescription drug product labeling](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.57) and [over-the-counter (OTC) drug product labeling](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.57).
-- Some fields are considered by the SPL specification as subsections of other fields, but labeling is not always formatted according to the specification. For example, information about prescription drugs’ potential `teratogenic effects` are ordinarily encoded in the teratogenic_effects field, found after (as a subsection of) the `pregnancy` field. However, some labels combine all the content into the `pregnancy` field and do not have a `teratogenic_effects` field. Again, expect variation.
-- Some labeling features data encoded in the wrong fields. These errors may be corrected in subsequent versions of the product labeling.
-- "#### Field order"
-- Fields are ordered naturally, as they were found in the original product labeling. Expect variation in field order from product to product.
-- "#### Tables"
-- Manufacturers sometimes supply product labeling with HTML tables that summarize data, such as adverse reactions. These tables usually accompany other text describing the data. When these tables are encountered, openFDA puts the HTML tables in their own field, with a `_table` suffix.
-- example: tables
-- "Here are common examples you may see:"
-- ul:
- - "`drug_interactions` accompanied by `drug_interactions_table`"
- - "`adverse_reactions` accompanied by `adverse_reactions_table`"
- - "`how_supplied` accompanied by `how_supplied_table`"
-- "`_table` fields are each tables that are encoded as HTML, one table per string."
-- "## Field-by-field reference"
-- Fields and their contents will vary from product to product. There are major differences between prescription drugs and OTC drugs, for example. The following descriptions are as accurate as possible but do not cover all the potential variation among field contents.
-- This page groups fields conceptually for ease of reference. In API results, fields will be ordered naturally as in the product labeling submission.
-- There are records with fields that are not documented here and that are not ordinarily part of human drug product labeling, such as `veterinary_indications`. This is usually the result of a data error in the SPL submission.
-- "### ID and version"
-- "All drug product labeling records contain these fields, which uniquely identify individual records."
-- example: results
-- fields:
- - set_id
- - id
- - version
- - effective_time
-- "### Abuse and overdosage"
-- fields:
- - drug_abuse_and_dependence
- - controlled_substance
- - abuse
- - dependence
- - overdosage
-- "### Adverse effects and interactions"
-- fields:
- - adverse_reactions
- - drug_interactions
- - drug_and_or_laboratory_test_interactions
-- "### Clinical pharmacology"
-- fields:
- - clinical_pharmacology
- - mechanism_of_action
- - pharmacodynamics
- - pharmacokinetics
-- "### Indications, usage, and dosage"
-- fields:
- - indications_and_usage
- - contraindications
- - dosage_and_administration
- - dosage_forms_and_strengths
- - purpose
- - description
- - active_ingredient
- - inactive_ingredient
- - spl_product_data_elements
-- "### Patient information"
-- fields:
- - spl_patient_package_insert
- - information_for_patients
- - information_for_owners_or_caregivers
- - instructions_for_use
- - ask_doctor
- - ask_doctor_or_pharmacist
- - do_not_use
- - keep_out_of_reach_of_children
- - other_safety_information
- - questions
- - stop_use
- - when_using
- - patient_medication_information
- - spl_medguide
-- "### Special populations"
-- fields:
- - use_in_specific_populations
- - pregnancy
- - teratogenic_effects
- - labor_and_delivery
- - nursing_mothers
- - pregnancy_or_breast_feeding
- - pediatric_use
- - geriatric_use
-- "### Nonclinical toxicology"
-- fields:
- - nonclinical_toxicology
- - carcinogenesis_and_mutagenesis_and_impairment_of_fertility
- - animal_pharmacology_and_or_toxicology
-- "### References"
-- fields:
- - clinical_studies
- - references
-- "### Supply, storage, and handling"
-- fields:
- - how_supplied
- - storage_and_handling
- - safe_handling_warning
-- "### Warnings and precautions"
-- fields:
- - boxed_warning
- - user_safety_warnings
- - precautions
- - warnings
- - general_precautions
-- "### Other fields"
-- fields:
- - laboratory_tests
- - recent_major_changes
- - microbiology
- - package_label_principal_display_panel
- - spl_unclassified_section
-- "### OpenFDA fields"
-- Different datasets use different drug identifiers—brand name, generic name, NDA, NDC, etc. It can be difficult to find the same drug in different datasets. And some identifiers, like pharmacologic class, are useful search filters but not available in all datasets.
-- OpenFDA features harmonization of drug identifiers, to make it easier to connect adverse event report records to other drug information. Drug products that appear in FAERS records are joined to the NDC dataset first on brand name, and if there is no brand name, on generic name. If that is succesful, further links are established to other datasets. The linked data is listed as an `openfda` annotation in the patient.drug section of a result.
-- Roughly 86% of adverse event records have at least one `openfda` section. Because the harmonization process requires an exact match, some drug products cannot be harmonized in this fashion—for instance, if the drug name is misspelled. Some drug products will have `openfda` sections, while others will never, if there was no match during the harmonization process.
-- fields:
- - openfda
-- "datasets"
diff --git a/pages/api_endpoints/drug/label/_examples.json b/pages/api_endpoints/drug/label/_examples.json
deleted file mode 100644
index 8edc58cb..00000000
--- a/pages/api_endpoints/drug/label/_examples.json
+++ /dev/null
@@ -1,47 +0,0 @@
-{
- "anatomy": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- },
- "results": [
- {}
- ]
- },
- "meta": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- }
- },
- "tables": {
- "results": [
- {
- "how_supplied": "...",
- "how_supplied_table": "
...
"
- }
- ]
- },
- "results": {
- "results": [
- {
- "set_id": "e71151ba-f2f4-4e95-9256-3db361d40a54",
- "id": "93321bf0-d58d-4ac1-bfa7-cb033ca9df85",
- "version": "2",
- "effective_time": "20140423"
- }
- ]
- }
-}
diff --git a/pages/api_endpoints/drug/label/_explorers.yaml b/pages/api_endpoints/drug/label/_explorers.yaml
deleted file mode 100644
index 59830d4a..00000000
--- a/pages/api_endpoints/drug/label/_explorers.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-oneLabel:
- params:
- - search for all records with effective_time between Jun 01, 2011 and Dec 31, 2012.
- - limit to 1 record.
- query: 'https://api.fda.gov/drug/label.json?search=effective_time:[20110601+TO+20121231]&limit=1'
- description:
- - This query searches for all records in a certain date range, and asks for a single one.
- - See the [reference](/drug/label/reference/) for more about effective_time. Brackets [ ] are used to specify a range for date, number, or string fields.
- title: One drug product labeling record
-boxedWarning:
- params:
- - search for all records with a boxed_warning field.
- - limit to 1 record.
- query: 'https://api.fda.gov/drug/label.json?search=_exists_:boxed_warning'
- description:
- - This query searches for labels with a Boxed Warning, and returns one result.
- - The `_exists_` search modifier lets you search for records that contain a specific field, no matter what its contents are. See the [API basics page](/api/) for more details.
- title: Product labeling record with a Boxed Warning
-countByType:
- params:
- - count the field openfda.product_type (product type).
- query: 'https://api.fda.gov/drug/label.json?count=openfda.product_type.exact'
- description:
- - There are more labeling records for over-the-counter (OTC) drugs than prescription drugs.
- - The suffix .exact is required by openFDA to count the unique full phrases in the field openfda.product_type. Without it, the API will count each word in that field individually—HUMAN OTC DRUG would be counted as separate values, HUMAN and OTC and DRUG.
- title: Count of drug labeling, by product type
diff --git a/pages/api_endpoints/drug/label/_fields.yaml b/pages/api_endpoints/drug/label/_fields.yaml
deleted file mode 100644
index ec4bb0a0..00000000
--- a/pages/api_endpoints/drug/label/_fields.yaml
+++ /dev/null
@@ -1,1025 +0,0 @@
-properties:
- abuse:
- area: "prescription"
- items:
- description: "Information about the types of abuse that can occur with the drug and adverse reactions pertinent to those types of abuse, primarily based on human data. May include descriptions of particularly susceptible patient populations."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- accessories:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- active_ingredient:
- area: "few prescription / OTC"
- items:
- description: "A list of the active, medicinal ingredients in the drug product."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- adverse_reactions:
- area: "prescription / some OTC"
- items:
- description: "Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- alarms:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- animal_pharmacology_and_or_toxicology:
- area: "some prescription"
- items:
- description: "Information from studies of the drug in animals, if the data were not relevant to nor included in other parts of the labeling. Most labels do not contain this field."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- ask_doctor:
- area: "few prescription / many OTC"
- items:
- description: "Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- ask_doctor_or_pharmacist:
- area: "very few prescription / some OTC"
- items:
- description: "Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- assembly_or_installation_instructions:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- boxed_warning:
- area: "some prescription / few OTC"
- items:
- description: "Information about contraindications or serious warnings, particularly those that may lead to death or serious injury."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- calibration_instructions:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- carcinogenesis_and_mutagenesis_and_impairment_of_fertility:
- area: "most prescription / very few OTC"
- items:
- description: "Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the `warnings` field."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- cleaning:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- clinical_pharmacology:
- area: "prescription / few OTC"
- items:
- description: "Information about the clinical pharmacology and actions of the drug in humans."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- clinical_studies:
- area: "some prescription / few OTC"
- items:
- description: "This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- compatible_accessories:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- components:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- contraindications:
- area: "prescription / few OTC"
- items:
- description: "Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- controlled_substance:
- area: "prescription"
- items:
- description: "Information about the schedule in which the drug is controlled by the Drug Enforcement Administration, if applicable."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- dependence:
- area: "prescription"
- items:
- description: "Information about characteristic effects resulting from both psychological and physical dependence that occur with the drug, the quantity of drug over a period of time that may lead to tolerance or dependence, details of adverse effects related to chronic abuse and the effects of abrupt withdrawl, procedures necessary to diagnose the dependent state, and principles of treating the effects of abrupt withdrawal."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- description:
- area: "prescription / some OTC"
- items:
- description: "General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- diagram_of_device:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- disposal_and_waste_handling:
- area: "Documentation forthcoming."
- items:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- do_not_use:
- area: "few prescription / many OTC"
- items:
- description: "Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- dosage_and_administration:
- area: "prescription / OTC"
- items:
- description: "Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- dosage_forms_and_strengths:
- area: "prescription / few OTC"
- items:
- description: "Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- drug_abuse_and_dependence:
- type: array
- about: "prescription"
- items:
- description: "Information about whether the drug is a controlled substance, the types of abuse that can occur with the drug, and adverse reactions pertinent to those types of abuse."
- format:
- is_exact: false
- possible_values:
- type: string
- drug_and_or_laboratory_test_interactions:
- items:
- description: "Information about any known interference by the drug with laboratory tests."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- drug_interactions:
- area: "prescription / few OTC"
- items:
- description: "Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- effective_time:
- description: "Date reference to the particular version of the labeling document."
- format: date
- is_exact: false
- pattern: "YYYYmmdd"
- type: string
- environmental_warning:
- items:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- food_safety_warning:
- items:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- general_precautions:
- area: "many prescription / few OTC"
- items:
- description: "Information about any special care to be exercised for safe and effective use of the drug."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- geriatric_use:
- area: "most prescription / very few OTC"
- items:
- description: "Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- guaranteed_analysis_of_feed:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- health_care_provider_letter:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- health_claim:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- how_supplied:
- area: "prescription / few OTC"
- items:
- description: "Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- id:
- description: "The document ID, A globally unique identifier (GUID) for the particular revision of a labeling document."
- format:
- is_exact: false
- possible_values:
- type: string
- inactive_ingredient:
- area: "few prescription / OTC"
- items:
- description: "A list of inactive, non-medicinal ingredients in a drug product."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- indications_and_usage:
- area: "prescription / OTC"
- items:
- description: "A statement of each of the drug product’s indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- information_for_owners_or_caregivers:
- area: "few prescription / few OTC"
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- information_for_patients:
- area: "prescription / some OTC"
- items:
- description: "Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- instructions_for_use:
- area: "some prescription / some OTC"
- items:
- description: "Information about safe handling and use of the drug product."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- intended_use_of_the_device:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- keep_out_of_reach_of_children:
- area: "few prescription / OTC"
- items:
- description: "Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- labor_and_delivery:
- area: "some prescription"
- items:
- description: "Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- laboratory_tests:
- area: "some prescription"
- items:
- description: "Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- mechanism_of_action:
- area: "prescription"
- items:
- description: "Information about the established mechanism(s) of the drug’s action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- microbiology:
- area: "some prescription"
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- nonclinical_toxicology:
- area: "some prescription"
- items:
- description: "Information about toxicology in non-human subjects."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- nonteratogenic_effects:
- area: "some prescription"
- items:
- description: "Other information about the drug’s effects on reproduction and the drug’s use during pregnancy, if the information is relevant to the safe and effective use of the drug."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- nursing_mothers:
- area: "prescription / very few OTC"
- items:
- description: "Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- openfda:
- type: object
- properties:
- application_number:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[BLA|ANDA|NDA]{3,4}[0-9]{6}$
- description: "This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null."
- possible_values:
- brand_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Brand or trade name of the drug product."
- possible_values:
- generic_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Generic name(s) of the drug product."
- possible_values:
- manufacturer_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC."
- possible_values:
- nui:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[N][0-9]{10}$
- description: "Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT)."
- possible_values:
- type: reference
- value:
- name: "NDF-RT"
- link: "https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NDFRT/"
- package_ndc:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{5,4}-[0-9]{4,3}-[0-9]{1,2}$
- description: "This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug."
- possible_values:
- pharm_class_cs:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]."
- possible_values:
- pharm_class_epc:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`."
- possible_values:
- pharm_class_pe:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`."
- possible_values:
- pharm_class_moa:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`."
- possible_values:
- product_ndc:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{5,4}-[0-9]{4,3}$
- description: "The labeler manufacturer code and product code segments of the NDC number, separated by a hyphen."
- possible_values:
- product_type:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description:
- possible_values:
- type: reference
- value:
- name: "Type of drug product"
- link: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162063.htm
- route:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The route of administation of the drug product."
- possible_values:
- type: reference
- value:
- name: "Route of administration"
- link: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162034.htm
- rxcui:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{6}$
- description: "The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms."
- possible_values:
- type: reference
- value:
- name: "RxNorm and RxCUI documentation"
- link: "https://www.nlm.nih.gov/research/umls/rxnorm/docs/2012/rxnorm_doco_full_2012-3.html"
- spl_id:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$
- description: "Unique identifier for a particular version of a Structured Product Label for a product. Also referred to as the document ID."
- possible_values:
- spl_set_id:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$
- description: "Unique identifier for the Structured Product Label for a product, which is stable across versions of the label. Also referred to as the set ID."
- possible_values:
- substance_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The list of active ingredients of a drug product."
- possible_values:
- unii:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[A-Z0-9]{10}$
- description: "Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information."
- possible_values:
- type: reference
- value:
- name: "Unique Ingredient Identifiers"
- link: "http://fdasis.nlm.nih.gov/srs/srs.jsp"
- upc:
- type: array
- items:
- type: string
- description: "Universal Product Code"
- format:
- is_exact: true
- possible_values:
- type: reference
- value:
- name: "Universal Product Code"
- link: "https://en.wikipedia.org/wiki/Universal_Product_Code"
- other_safety_information:
- area: "few prescription / some OTC"
- items:
- description: "Information about safe use and handling of the product that may not have been specified in another field."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- overdosage:
- area: "prescription / some OTC"
- items:
- description: "Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- package_label_principal_display_panel:
- area: "prescription / OTC"
- items:
- description: "The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- patient_medication_information:
- area: "few prescription"
- items:
- description: "Information or instructions to patients about safe use of the drug product, sometimes including a reference to a patient medication guide or counseling materials."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- pediatric_use:
- area: "prescription / very few OTC"
- items:
- description: "Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- pharmacodynamics:
- area: "prescription"
- items:
- description: "Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drug’s clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- pharmacogenomics:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- pharmacokinetics:
- area: "prescription"
- items:
- description: "Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- precautions:
- area: "many prescription / few OTC"
- items:
- description: "Information about any special care to be exercised for safe and effective use of the drug."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- pregnancy:
- area: "prescription / few OTC"
- items:
- description: "Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the `teratogenic_effects` field, but may be listed here instead.)"
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- pregnancy_or_breast_feeding:
- area: "many prescription / few OTC"
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- purpose:
- area: "few prescription / OTC"
- items:
- description: "Information about the drug product’s indications for use."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- questions:
- area: "few prescription / many OTC"
- items:
- description: "A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- recent_major_changes:
- area: "some prescription"
- items:
- description: "A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- references:
- area: "some prescription / few OTC"
- items:
- description: "This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- residue_warning:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- risks:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- route:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- safe_handling_warning:
- area: "very few prescription / few OTC"
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- set_id:
- description: "The Set ID, A globally unique identifier (GUID) for the labeling, stable across all versions or revisions."
- format:
- is_exact: false
- possible_values:
- type: string
- spl_indexing_data_elements:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- spl_medguide:
- area: "some prescription"
- items:
- description: "Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- spl_patient_package_insert:
- area: "prescription / few OTC"
- items:
- description: "Information necessary for patients to use the drug safely and effectively."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- spl_product_data_elements:
- area: "prescription / OTC"
- items:
- description: "Usually a list of ingredients in a drug product."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- spl_unclassified_section:
- area: "some prescription / some OTC"
- items:
- description: "Information not classified as belonging to one of the other fields. Approximately 40% of labeling with `effective_time` between June 2009 and August 2014 have information in this field."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- statement_of_identity:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- stop_use:
- area: "few prescription / many OTC"
- items:
- description: "Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- storage_and_handling:
- area: "many prescription / many OTC"
- items:
- description: "Information about safe storage and handling of the drug product."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- summary_of_safety_and_effectiveness:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- teratogenic_effects:
- area: "some prescription"
- items:
- description: "_Pregnancy category A_: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters.\n_Pregnancy category B_: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.\n_Pregnancy category C_: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.\n_Pregnancy category D_: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective).\n_Pregnancy category X_: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available)."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- troubleshooting:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- use_in_specific_populations:
- area: "some prescription / very few OTC"
- items:
- description: "Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- user_safety_warnings:
- area: "very few prescription / very few OTC"
- items:
- description: "When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- version:
- description: "A sequentially increasing number identifying the particular version of a document, starting with `1`."
- format:
- is_exact: false
- possible_values:
- type: string
- warnings:
- area: "prescription / OTC"
- items:
- description: "Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- warnings_and_cautions:
- items:
- description: "Documentation forthcoming."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- when_using:
- area: "few prescription / many OTC"
- items:
- description: "Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product."
- format:
- is_exact: false
- possible_values:
- type: string
- type: array
- meta:
- format:
- type: object
- description: 'This section contains a disclaimer and license information. The field `last_updated` indicates when the data files were exported.'
- possible_values:
- properties:
- type: object
- disclaimer:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Important details notes about openFDA data and limitations of the dataset."
- possible_values:
- license:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Link to a web page with license terms that govern data within openFDA."
- possible_values:
- last_updated:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "The last date when this openFDA endpoint was updated. Note that this does not correspond to the most recent record for the endpoint or dataset. Rather, it is the last time the openFDA API was itself updated."
- possible_values:
- results:
- type: object
- properties:
- skip:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Offset (page) of results, defined by the `skip` [query parameter](/api/)."
- possible_values:
- limit:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Number of records in this return, defined by the `limit` [query parameter](/api/). If there is no `limit` parameter, the API returns one result."
- possible_values:
- total:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Total number of records matching the search criteria."
- possible_values:
-type: object
diff --git a/pages/api_endpoints/drug/label/_infographics.yaml b/pages/api_endpoints/drug/label/_infographics.yaml
deleted file mode 100644
index 458881b0..00000000
--- a/pages/api_endpoints/drug/label/_infographics.yaml
+++ /dev/null
@@ -1,54 +0,0 @@
-- title: "Prescription and over-the-counter (OTC) drug labeling"
- short: "Submissions over time"
- dataset: SPL
- description:
- - "The openFDA drug product labeling API provides data for prescription and over-the-counter (OTC) drug labeling. Since mid-2009, labeling has been posted publicly in the [Structured Product Labeling (SPL) format](/data/spl/)."
- - "This chart shows labeling submissions over time, by looking at their 'effective dates.' The search is limited to dates since June 2009, which excludes a small number of older submissions."
- countParam: "effective_time"
- filters:
- - title: "All drug labeling submissions"
- searchParam: ""
- - title: "Over-the-counter drug labeling"
- searchParam: "openfda.product_type:otc"
- - title: "Prescription drug labeling"
- searchParam: "openfda.product_type:prescription"
- - title: "Lactose is an inactive ingredient"
- searchParam: "inactive_ingredient:lactose"
- - title: "Labeling has a Boxed Warning"
- searchParam: "_exists_:boxed_warning"
- type: Line
- dateConstraint: effective_time
-- title: "Routes of administration"
- short: "Routes of administration"
- dataset: SPL
- description:
- - "Most drug product labeling describes a drug with a single route of administration—oral, intravenous, topical, and so forth. Click the buttons below to see the top routes of administration noted in various kinds of drug product labeling."
- countParam: "openfda.route.exact"
- filters:
- - title: "All drug labeling submissions"
- searchParam: ""
- - title: "Over-the-counter drug labeling"
- searchParam: "openfda.product_type:otc"
- - title: "Prescription drug labeling"
- searchParam: "openfda.product_type:prescription"
- - title: "Indication or purpose notes the word migraine"
- searchParam: 'indications_and_usage:"migraine"+purpose:"migraine"'
- - title: "Labeling has a Boxed Warning with the word bleeding in it"
- searchParam: "boxed_warning:bleeding"
- type: Line
- dateConstraint: false
-- title: "Drug interactions noted in labeling"
- short: "Drug interactions"
- dataset: SPL
- description:
- - Drug product labeling must indicate known interactions with foods and other drug products. This chart shows top classes of drugs whose labeling notes caffeine, grapefruit, or alcohol in the interactions section.
- countParam: "openfda.pharm_class_epc.exact"
- filters:
- - title: "Labeling noting caffeine in the interactions section"
- searchParam: "drug_interactions:caffeine"
- - title: "Labeling noting grapefruit juice in the interactions section"
- searchParam: 'drug_interactions:"grapefruit"+juice'
- - title: "Labeling noting alcohol in the interactions section"
- searchParam: "drug_interactions:alcohol"
- type: Line
- dateConstraint: false
diff --git a/pages/api_endpoints/drug/label/_meta.yaml b/pages/api_endpoints/drug/label/_meta.yaml
deleted file mode 100644
index 39acd678..00000000
--- a/pages/api_endpoints/drug/label/_meta.yaml
+++ /dev/null
@@ -1,13 +0,0 @@
-documentTitle: openFDA › Drugs › Labeling API
-name: Drug Labeling
-description: ""
-datasets:
- - SPL
-label: Drug labeling
-title: Drug Labeling
-path: /api_endpoints/drug/label
-api_path: /drug/label
-start: 20090601
-status: druglabel
-dateConstraintKey: effective_time
-type: endpoint
diff --git a/pages/api_endpoints/drug/label/index.jsx b/pages/api_endpoints/drug/label/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/drug/label/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/food/_content.yaml b/pages/api_endpoints/food/_content.yaml
deleted file mode 100644
index 119a0352..00000000
--- a/pages/api_endpoints/food/_content.yaml
+++ /dev/null
@@ -1,8 +0,0 @@
-- url: /food/enforcement/
- title: Food recall enforcement reports
- description:
- - "Food product recall enforcement reports."
-- url: /food/event/
- title: Food, dietary supplement, and cosmetic adverse event reports
- description:
- - "Food, dietary supplement, and cosmetic adverse event reports."
\ No newline at end of file
diff --git a/pages/api_endpoints/food/_meta.yaml b/pages/api_endpoints/food/_meta.yaml
deleted file mode 100644
index 76cbcc84..00000000
--- a/pages/api_endpoints/food/_meta.yaml
+++ /dev/null
@@ -1,6 +0,0 @@
-documentTitle: openFDA › Foods
-label: API categories
-title: Foods
-description: "The U.S. Food and Drug Administration (FDA) is responsible for ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled."
-path: /api_endpoints/food/
-type: noun
diff --git a/pages/api_endpoints/food/_template.jsx b/pages/api_endpoints/food/_template.jsx
deleted file mode 100644
index b9e477f8..00000000
--- a/pages/api_endpoints/food/_template.jsx
+++ /dev/null
@@ -1,2 +0,0 @@
-import React from 'react'
-export default (props) => props.children
diff --git a/pages/api_endpoints/food/enforcement/_content.yaml b/pages/api_endpoints/food/enforcement/_content.yaml
deleted file mode 100644
index 0e464f39..00000000
--- a/pages/api_endpoints/food/enforcement/_content.yaml
+++ /dev/null
@@ -1,78 +0,0 @@
-- "## About food recalls and enforcement reports"
-- "Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA). Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or civil actions, especially when the product has been widely distributed."
-- "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
-- "## Enforcement reports"
-- "An enforcement report contains information on actions taken in connection with FDA regulatory activities. The data served by this API endpoint includes enforcement reports about device product recalls."
-- "This API should not be used as a method to collect data to issue alerts to the public. FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. Subscribe to this Recall/Safety Alert feed here."
-- "Whereas not all recalls are announced in the media or on our recall press release page all FDA-monitored recalls go into FDA’s Enforcement Report once they are classified according to the level of hazard involved. For more information, see FDA 101: Product Recalls from First Alert to Effectiveness Checks."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/food/enforcement.json` using search parameters for fields specific to the food recalls enforcement reports endpoint."
-- queryExplorer: oneReport
-- queryExplorer: hazard
-- queryExplorer: voluntaryVsMandated
-- "## Data reference"
-- "The openFDA food enforcement reports API returns data from the [FDA Recall Enterprise System (RES)](/data/res/), a database that contains information on recall event information submitted to FDA. Currently, this data covers publically releasable records from 2004-present. The data is updated weekly."
-- "The procedures followed to input recall information into RES when FDA learns of a recall event are outlined in [Chapter 7 of FDA’s Regulatory Procedure Manual](http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm177304.htm). The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters."
-- disclaimer:
- - "This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall. FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. [Subscribe to this Recall/Safety Alert feed here](http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Recalls/rss.xml)."
- - "Further, FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports."
-- "When necessary, the FDA will make corrections or changes to recall information previously disclosed in a past Enforcement Report for various reasons. For instance, the firm may discover that the initial recall should be expanded to include more batches or lots of the same recalled product than formerly reported. For more information about corrections or changes implemented, please refer to the Enforcement Report’s [Changes to Past Enforcement Reports” page](http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm345487.htm)."
-- "### What are enforcement reports?"
-- "An enforcement report contains information on actions taken in connection with FDA regulatory activities. The data served by this API endpoint includes enforcement reports about drug product recalls."
-- "Whereas not all recalls are announced in the media or on [FDA’s Recalls press release page](http://www.fda.gov/Safety/recalls/default.htm), all recalls montiored by FDA are included in [FDA’s weekly Enforcement Report](http://www.fda.gov/%20Safety/Recalls/EnforcementReports/default.htm) once they are classified according to the level of hazard involved."
-- "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
-- "### Downloads"
-- "downloads"
-- "### Anatomy of a response"
-- "This is a simulated openFDA API return for a non-`count` query. It is divided into two high-level sections, `meta` and `results`."
-- example: anatomy
-- "### Meta"
-- "For non-`count` queries, the `meta` section includes a disclaimer, a link to the openFDA data license, and information about the results that follow."
-- example: meta
-- fields:
- - meta.disclaimer
- - meta.license
- - meta.last_updated
- - meta.results.skip
- - meta.results.limit
- - meta.results.total
-- "### Results"
-- "For non-`count` queries, the `results` section includes matching enforcement report records returned by the API, each of which has a set of fields describing the food product recall."
-- "The data format of RES enforcement reports changed in June 2012. In openFDA API results, reports from before that time do not contain the following fields:"
-- ul:
- - "`event_id`"
- - "`status`"
- - "`city`"
- - "`state`"
- - "`country`"
- - "`voluntary_mandated`"
- - "`initial_firm_notification`"
- - "`recall_initiation_date`"
-- "## Field-by-field reference"
-- "### Enforcement report"
-- example: result
-- fields:
- - recalling_firm
- - classification
- - status
- - distribution_pattern
- - product_description
- - code_info
- - reason_for_recall
- - product_quantity
- - voluntary_mandated
- - report_date
- - recall_initiation_date
- - initial_firm_notification
- - recall_number
- - event_id
- - product_type
-- "### Geographic data"
-- fields:
- - city
- - state
- - country
-- "### OpenFDA fields"
-- "For more information about the `openfda` section, see the [API reference](/api/reference/)."
-- "Food product recall enforcement reports will always have an empty `openfda` section."
-- "datasets"
diff --git a/pages/api_endpoints/food/enforcement/_examples.json b/pages/api_endpoints/food/enforcement/_examples.json
deleted file mode 100644
index 55c8853b..00000000
--- a/pages/api_endpoints/food/enforcement/_examples.json
+++ /dev/null
@@ -1,49 +0,0 @@
-{
- "anatomy": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- },
- "results": [
- {}
- ]
- },
- "meta": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- }
- },
- "result": {
- "reason_for_recall": "Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared soy (lecithin).",
- "status": "Ongoing",
- "distribution_pattern": "ND, AZ, MN, SD, KS",
- "product_quantity": "81 containers",
- "recall_initiation_date": "20120720",
- "state": "ND",
- "event_id": "62644",
- "product_type": "Food",
- "product_description": "Cass-Clay , Swiss Chip, 3 Gallon(11.34 L).",
- "country": "US",
- "city": "Fargo",
- "recalling_firm": "Cass Clay Creamery AMPI Fargo Division",
- "report_date": "20120905",
- "voluntary_mandated": "Voluntary: Firm Initiated",
- "classification": "Class II",
- "code_info": "all products that has a plant code of \"38-25\".",
- "openfda": {},
- "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit"
- }
-}
diff --git a/pages/api_endpoints/food/enforcement/_explorers.yaml b/pages/api_endpoints/food/enforcement/_explorers.yaml
deleted file mode 100644
index b5aa707f..00000000
--- a/pages/api_endpoints/food/enforcement/_explorers.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-oneReport:
- title: One enforcement report
- description:
- - "This query searches for all records in a certain date range, and asks for a single one."
- - "See the [reference](/food/enforcement/reference/) for more about report_date. Brackets `[ ]` are used to specify a range for date, number, or string fields."
- params:
- - "Search for all records with report_date between Jan 01, 2004 and Dec 31, 2013."
- - "Limit to 1 record."
- query: 'https://api.fda.gov/food/enforcement.json?search=report_date:[20040101+TO+20131231]&limit=1'
-hazard:
- title: One enforcement report of a certain health hazard class
- description:
- - "This query searches records of a certain health hazard, and returns a single record."
- - 'Double quotation marks `" "` surround phrases that must match exactly. The plus sign + is used in place of a space character ` `.'
- params:
- - "Search for all records where classification (health hazard level) was Class III."
- - "Limit to 1 record."
- query: 'https://api.fda.gov/food/enforcement.json?search=classification:"Class+III"&limit=1'
-voluntaryVsMandated:
- title: "Count of voluntary vs. mandated enforcement reports"
- description:
- - "The vast majority of recalls are firm-initiated. This query searches the endpoint for all records, and tells the API to count how many enforcement reports were for voluntary vs. FDA-mandated recalls."
- - "The suffix .exact is required by openFDA to count the unique full phrases in the field voluntary_mandated. Without it, the API will count each word in that field individually—Firm Initiated would be counted as separate values, Firm and Initiated."
- params:
- - "Count the field `voluntary_mandated` (type of recall)."
- query: 'https://api.fda.gov/food/enforcement.json?count=voluntary_mandated.exact'
diff --git a/pages/api_endpoints/food/enforcement/_fields.yaml b/pages/api_endpoints/food/enforcement/_fields.yaml
deleted file mode 100644
index 72df55c2..00000000
--- a/pages/api_endpoints/food/enforcement/_fields.yaml
+++ /dev/null
@@ -1,407 +0,0 @@
-properties:
- address_1:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- address_2:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- center_classification_date:
- description:
- format: date
- is_exact: false
- possible_values:
- type: string
- city:
- description: "The city in which the recalling firm is located."
- format:
- is_exact: true
- possible_values:
- type: string
- classification:
- description: "Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- "Class I": "Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve."
- "Class II": "Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations."
- "Class III": "Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food."
- type: string
- code_info:
- description: "A list of all lot and/or serial numbers, product numbers, packer or manufacturer numbers, sell or use by dates, etc., which appear on the product or its labeling."
- format:
- is_exact: false
- possible_values:
- type: string
- country:
- description: "The country in which the recalling firm is located."
- format:
- is_exact: true
- possible_values:
- type: string
- distribution_pattern:
- description: "General area of initial distribution such as, “Distributors in 6 states: NY, VA, TX, GA, FL and MA; the Virgin Islands; Canada and Japan”. The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included."
- format:
- is_exact: false
- possible_values:
- type: string
- event_id:
- description: "A numerical designation assigned by FDA to a specific recall event used for tracking purposes."
- format: int64
- is_exact: false
- possible_values:
- type: string
- initial_firm_notification:
- description: "The method(s) by which the firm initially notified the public or their consignees of a recall. A consignee is a person or firm named in a bill of lading to whom or to whose order the product has or will be delivered."
- format:
- is_exact: true
- possible_values:
- type: string
- more_code_info:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- openfda:
- properties:
- application_number:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- brand_name:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- dosage_form:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- generic_name:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- is_original_packager:
- description:
- format:
- is_exact: true
- possible_values:
- type: boolean
- manufacturer_name:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- nui:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- original_packager_product_ndc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- package_ndc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- pharm_class_cs:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- pharm_class_epc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- pharm_class_moa:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- pharm_class_pe:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- product_ndc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- product_type:
- items:
- description: "The type of product being recalled. For food queries, this will always be `Food`."
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- "Drugs": "The recalled product is a drug product."
- "Devices": "The recalled product is a device product."
- "Food": "The recalled product is a food product."
- type: string
- type: array
- route:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- rxcui:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- rxstring:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- rxtty:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- spl_id:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- spl_set_id:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- substance_name:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- unii:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- upc:
- items:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- type: array
- type: object
- product_code:
- description:
- format:
- is_exact: false
- possible_values:
- type: string
- product_description:
- description: "Brief description of the product being recalled."
- format:
- is_exact: false
- possible_values:
- type: string
- product_quantity:
- description: "The amount of defective product subject to recall."
- format:
- is_exact: false
- possible_values:
- type: string
- product_type:
- description:
- format:
- is_exact: true
- possible_values:
- type: string
- reason_for_recall:
- description: "Information describing how the product is defective and violates the FD&C Act or related statutes."
- format:
- is_exact: false
- possible_values:
- type: string
- recall_initiation_date:
- description: "Date that the firm first began notifying the public or their consignees of the recall."
- format: date
- is_exact: false
- possible_values:
- type: string
- recall_number:
- description: "A numerical designation assigned by FDA to a specific recall event used for tracking purposes."
- format:
- is_exact: true
- possible_values:
- type: string
- recalling_firm:
- description: "The firm that initiates a recall or, in the case of an FDA requested recall or FDA mandated recall, the firm that has primary responsibility for the manufacture and (or) marketing of the product to be recalled."
- format:
- is_exact: true
- possible_values:
- type: string
- report_date:
- description: "Date that the FDA issued the enforcement report for the product recall."
- format: date
- is_exact: false
- possible_values:
- type: string
- state:
- description: "The U.S. state in which the recalling firm is located."
- format:
- is_exact: true
- possible_values:
- type: string
- status:
- description:
- format:
- is_exact: true
- possible_values:
- type: one_of
- value:
- "On-Going": "A recall which is currently in progress."
- "Completed": "The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections."
- "Terminated": "FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard."
- "Pending": "Actions that have been determined to be recalls, but that remain in the process of being classified."
- type: string
- termination_date:
- description:
- format: date
- is_exact: false
- possible_values:
- type: string
- voluntary_mandated:
- description: "Describes who initiated the recall. Recalls are almost always voluntary, meaning initiated by a firm. A recall is deemed voluntary when the firm voluntarily removes or corrects marketed products or the FDA requests the marketed products be removed or corrected. A recall is mandated when the firm was ordered by the FDA to remove or correct the marketed products, under section 518(e) of the FD&C Act, National Childhood Vaccine Injury Act of 1986, 21 CFR 1271.440, Infant Formula Act of 1980 and its 1986 amendments, or the Food Safety Modernization Act (FSMA)."
- format:
- is_exact: true
- possible_values:
- type: string
- meta:
- format:
- type: object
- description: 'This section contains a disclaimer and license information. The field `last_updated` indicates when the data files were exported.'
- possible_values:
- properties:
- type: object
- disclaimer:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Important details notes about openFDA data and limitations of the dataset."
- possible_values:
- license:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Link to a web page with license terms that govern data within openFDA."
- possible_values:
- last_updated:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "The last date when this openFDA endpoint was updated. Note that this does not correspond to the most recent record for the endpoint or dataset. Rather, it is the last time the openFDA API was itself updated."
- possible_values:
- results:
- type: object
- properties:
- skip:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Offset (page) of results, defined by the `skip` [query parameter](/api/)."
- possible_values:
- limit:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Number of records in this return, defined by the `limit` [query parameter](/api/). If there is no `limit` parameter, the API returns one result."
- possible_values:
- total:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Total number of records matching the search criteria."
- possible_values:
-type: object
diff --git a/pages/api_endpoints/food/enforcement/_infographics.yaml b/pages/api_endpoints/food/enforcement/_infographics.yaml
deleted file mode 100644
index 8cc02a95..00000000
--- a/pages/api_endpoints/food/enforcement/_infographics.yaml
+++ /dev/null
@@ -1,36 +0,0 @@
-- title: "Food recall enforcement reports since 2012"
- short: "Enforcement reports over time"
- description:
- - "This is the openFDA API endpoint for all food product recalls monitored by the FDA. When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public."
- - "Recalls are almost always voluntary, meaning a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request or order a recall. But in every case, FDA's role is to oversee a company's strategy, classify the recalled products according to the level of hazard involved, and assess the adequacy of the recall. Recall information is posted in the Enforcement Reports once the products are classified."
- - "Important note: FDA is working to consolidate medical device recall information."
- countParam: "report_date"
- filters:
- - title: "All food product enforcement reports"
- searchParam: ""
- - title: 'Recalls mentioning "ice cream"'
- searchParam: 'reason_for_recall:"ice+cream"'
- type: Line
- dateConstraint: false
-- title: "The vast majority of food recalls are voluntary"
- short: "Who initiates?"
- description:
- - "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
- countParam: "voluntary_mandated.exact"
- filters:
- - title: "All food product enforcement reports"
- searchParam: ""
- type: Donut
- dateConstraint: false
-- title: "Many food product recalls are classified as a serious health hazard"
- short: "Seriousness"
- description:
- - "Recalls are classified into three categories: Class I, a dangerous or defective product that predictably could cause serious health problems or death, Class II, meaning that the product might cause a temporary health problem, or pose only a slight threat of a serious nature, and Class III, a product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws."
- countParam: "classification.exact"
- filters:
- - title: "All food product enforcement reports"
- searchParam: ""
- - title: 'Recalls mentioning "ice cream"'
- searchParam: 'reason_for_recall:"ice+cream"'
- type: Donut
- dateConstraint: false
diff --git a/pages/api_endpoints/food/enforcement/_meta.yaml b/pages/api_endpoints/food/enforcement/_meta.yaml
deleted file mode 100644
index 8f633fc6..00000000
--- a/pages/api_endpoints/food/enforcement/_meta.yaml
+++ /dev/null
@@ -1,12 +0,0 @@
-type: endpoint
-documentTitle: openFDA › Foods › Recall enforcement reports API
-label: Food recall enforcement reports
-title: Food Recall Enforcement Reports
-description: "Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA)."
-datasets:
- - RES
-path: /api_endpoints/food/enforcement
-api_path: /food/enforcement
-start: 20090101
-status: drugenforcement
-dateConstraintKey: termination_date
diff --git a/pages/api_endpoints/food/enforcement/index.jsx b/pages/api_endpoints/food/enforcement/index.jsx
deleted file mode 100644
index 6ac4a0ec..00000000
--- a/pages/api_endpoints/food/enforcement/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/food/event/_content.yaml b/pages/api_endpoints/food/event/_content.yaml
deleted file mode 100644
index 5dbb73ee..00000000
--- a/pages/api_endpoints/food/event/_content.yaml
+++ /dev/null
@@ -1,77 +0,0 @@
-- "## About food, dietary supplement, and cosmetic adverse events"
-- "The U.S. Food and Drug Administration (FDA) regulates food products in the United States, working to assure that the food supply is safe, sanitary, wholesome, and honestly labeled. FDA's responsibility covers all domestic and imported food except meat, poultry, and frozen, dried, and liquid eggs, and the labeling of alcoholic beverages (above 7% alcohol). It even includes dietary supplements, bottled water, food additives, infant formulas, and other food products. The FDA also regulates all cosmetic products and ingredients in the United States, including hair products, makeup, soaps, and lotions."
-- "An adverse event is submitted to the FDA to report adverse health effects and product complaints about foods, dietary supplements, and cosmetics. These may include side effects, product use errors, and product quality problems. Reporting is voluntary for beverages, conventional foods, dietary supplements, and cosmetics, which means that manufacturers and citizens may report them at any time but are not obligated to. For dietary supplements, manufacturers, packers, and distributers must notify the FDA if they receive reports about serious adverse events in connection with the use of their products."
-- "### Adverse event reports"
-- "Even with mandatory reporting of serious adverse events for dietary supplements, generally only a small fraction of adverse events associated with any product is reported."
-- "A report may list several products, as well as several reactions that the consumer experienced. No individual food, dietary supplements, or cosmetic product is connected to any individual reaction. When a report lists multiple products and multiple reactions, there is no way to conclude from the data therein that a given product is responsible for a given reaction."
-- "Reports to FDA do not necessarily include all relevant data, such as whether an individual also suffered from other medical conditions (such as cardiac disease) or took other supplements or medication at the same time. They also may not include accurate or complete contact information for FDA to seek further information about the event, or complainants may choose not to participate in the follow-up investigation."
-- "When important information is missing from a report, it is difficult for FDA to fully evaluate whether the product caused the adverse event or simply coincided with it. The fact that an adverse event happened after a person took a dietary supplement does not necessarily mean that the dietary supplement caused the adverse event."
-- "### How to search this endpoint"
-- "Make API calls to `https://api.fda.gov/food/event.json` using search parameters for fields specific to the food adverse events endpoint."
-- queryExplorer: oneReport
-- queryExplorer: industry
-- queryExplorer: reaction
-- "## Data reference"
-- "The openFDA food, dietary supplements, and cosmetic adverse event API returns data from the [Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS)](/data/caers/), a database that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics. The database is designed to support CFSAN's safety surveillance program."
-- "For more information about the CAERS data, please see this web page: [http://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm](http://www.fda.gov/Food/ComplianceEnforcement/ucm494015.htm)."
-- "### How adverse events are organized"
-- "Each report received regarding an individual that experiences an adverse event is assigned a unique report number."
-- "### Downloads"
-- "downloads"
-- "## Anatomy of a response"
-- "This is a simulated openFDA API return for a non-`count` query. It is divided into two high-level sections, `meta` and `results`."
-- example: anatomy
-- "### Meta"
-- "For non-`count` queries, the `meta` section includes a disclaimer, a link to the openFDA data license, and information about the results that follow."
-- example: meta
-- fields:
- - meta.disclaimer
- - meta.license
- - meta.last_updated
- - meta.results.skip
- - meta.results.limit
- - meta.results.total
-- "### Results"
-- "For non-`count` queries, the `results` section includes matching adverse event reports returned by the API."
-- "Each adverse event report consists of these major sections:"
-- ul:
- - "Header: General information about the adverse event report"
- - "Consumer: Information about the individual who experienced the adverse event"
- - "Products: Information about the products involved in the adverse event report"
- - "Reactions: Information on the reactions or symptoms experienced by the individual involved"
- - "Outcomes: Information on known outcomes or consequences of the adverse event"
-- example: results
-- "## Field-by-field reference"
-- "### Header"
-- "General information about the adverse event report."
-- example: header
-- fields:
- - report_number
- - date_created
- - date_started
-- "### Consumer"
-- "Information about the individual who consumed or used the product and was affected in the adverse event report."
-- example: consumer
-- fields:
- - consumer.gender
- - consumer.age
- - consumer.age_unit
-- "#### Products"
-- "This section contains information about the products listed in the adverse event report."
-- example: products
-- fields:
- - products
- - products.name_brand
- - products.industry_name
- - products.industry_code
-- "#### Reactions"
-- "This section lists reactions (or symptoms) the individual experienced after consuming or using the products listed in the adverse event report."
-- example: reactions
-- fields:
- - reactions
-- "#### Outcomes"
-- "This section lists known outcomes or consequences of the adverse event, such as whether the individual required hospitalization."
-- example: outcomes
-- fields:
- - outcomes
-- "datasets"
diff --git a/pages/api_endpoints/food/event/_examples.json b/pages/api_endpoints/food/event/_examples.json
deleted file mode 100644
index c6031798..00000000
--- a/pages/api_endpoints/food/event/_examples.json
+++ /dev/null
@@ -1,101 +0,0 @@
-{
- "anatomy": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- },
- "results": [
- {}
- ]
- },
- "meta": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- }
- },
- "results": {
- "report_number": "65325",
- "date_created": "20040101",
- "date_started": "20030804",
- "consumer": {
- "gender": "Female",
- "age": "2",
- "age_unit": "Year(s)"
- },
- "products": [
- {
- "name_brand": "MIDWEST COUNTRY FAIR CHOCOLATE FLAVORED CHIPS",
- "industry_name": "Bakery Prod/Dough/Mix/Icing",
- "industry_code": "3",
- "role": "Suspect"
- }
- ],
- "reactions": [
- "SWELLING FACE",
- "WHEEZING",
- "COUGH",
- "RASH",
- "HOSPITALISATION",
- "DYSPNOEA"
- ],
- "outcomes": [
- "VISITED AN ER",
- "VISITED A HEALTH CARE PROVIDER",
- "REQ. INTERVENTION TO PRVNT PERM. IMPRMNT.",
- "HOSPITALIZATION"
- ]
- },
- "header": {
- "report_number": "65325",
- "date_created": "20040101",
- "date_started": "20030804"
- },
- "consumer": {
- "consumer": {
- "gender": "Female",
- "age": "2",
- "age_unit": "Year(s)"
- }
- },
- "products": {
- "products": [
- {
- "name_brand": "MIDWEST COUNTRY FAIR CHOCOLATE FLAVORED CHIPS",
- "industry_name": "Bakery Prod/Dough/Mix/Icing",
- "industry_code": "3",
- "role": "Suspect"
- }
- ]
- },
- "reactions": {
- "reactions": [
- "SWELLING FACE",
- "WHEEZING",
- "COUGH",
- "RASH",
- "HOSPITALISATION",
- "DYSPNOEA"
- ]
- },
- "outcomes": {
- "outcomes": [
- "VISITED AN ER",
- "VISITED A HEALTH CARE PROVIDER",
- "REQ. INTERVENTION TO PRVNT PERM. IMPRMNT.",
- "HOSPITALIZATION"
- ]
- }
-}
diff --git a/pages/api_endpoints/food/event/_explorers.yaml b/pages/api_endpoints/food/event/_explorers.yaml
deleted file mode 100644
index dd800438..00000000
--- a/pages/api_endpoints/food/event/_explorers.yaml
+++ /dev/null
@@ -1,28 +0,0 @@
-oneReport:
- title: One adverse event report
- description:
- - This query searches for all records in a certain date range, and asks for a single one.
- - See the [header fields reference](/food/event/reference/) for more about date_started. Brackets [ ] are used to specify a range for date, number, or string fields.
- params:
- - search for all records with receivedate between Jan 01, 2004 and Jan 1, 2016.
- - limit to 1 record.
- query: 'https://api.fda.gov/food/event.json?search=date_started:[20040101+TO+20160101]&limit=1'
-industry:
- title: One adverse event report involving a product from a certain industry
- description:
- - 'This query searches records listing a product associated with a certain industry, and returns a single record.'
- params:
- - search for all records where products.industry_code (FDA industry code) contains 23 (Nuts/Edible Seed).
- - limit to 1 record.
- query: 'https://api.fda.gov/food/event.json?search=products.industry_code:23&limit=1'
-reaction:
- title: Count of consumer reactions
- description:
- - This query is similar to the prior one, but returns a count of the 1000 most frequently reported consumer reactions.
- - count the field reaction.exact (consumer reactions).
- - The suffix .exact is required by openFDA to count the unique full phrases in the field reactions. Without it, the API will count each word in that field individually—difficulty sleeping would be counted as separate values, difficulty and sleeping.
- - See the [reaction reference](/food/event/reference/) for more about consumer reactions in adverse event records.
- params:
- - search for all records where products.industry_code (FDA industry code) contains 23 (cereal prep/breakfast food).
- - limit to 1 record.
- query: 'https://api.fda.gov/food/event.json?search=products.industry_code:23&count=reactions.exact'
diff --git a/pages/api_endpoints/food/event/_fields.yaml b/pages/api_endpoints/food/event/_fields.yaml
deleted file mode 100644
index 45c28b2b..00000000
--- a/pages/api_endpoints/food/event/_fields.yaml
+++ /dev/null
@@ -1,264 +0,0 @@
-properties:
- consumer:
- properties:
- age:
- description: "The reported age of the consumer at the time of the adverse event report, expressed in the unit in the field `age_unit`."
- format:
- is_exact: false
- possible_values:
- type: string
- age_unit:
- description: "Encodes the unit in which the age of the consumer is expressed."
- possible_values:
- type: one_of
- value:
- "Day(s)": "age is expressed in days"
- "Week(s)": "age is expressed in weeks"
- "Month(s)": "age is expressed in months"
- "Year(s)": "age is expressed in years"
- "Decade(s)": "age is expressed in decades"
- "Not Available": "Unknown"
- format:
- is_exact: false
- type: string
- gender:
- description: "The reported gender of the consumer."
- possible_values:
- type: one_of
- value:
- "Female": "Female"
- "Male": "Male"
- "Not Available": "Unknown"
- format:
- is_exact: false
- type: string
- type: object
- date_created:
- description: "Date the report was received by FDA."
- format: date
- is_exact: false
- possible_values:
- type: string
- date_started:
- description: "Date of the adverse event (when it was considered to have started)."
- format: date
- is_exact: false
- possible_values:
- type: string
- outcomes:
- items:
- description: "The outcome or consequence of the adverse event."
- possible_values:
- type: one_of
- value:
- "NON-SERIOUS INJURIES/ ILLNESS": "The outcome wasn’t serious"
- "OTHER SERIOUS (IMPORTANT MEDICAL EVENTS)": "The outcome included non-specified serious medical events"
- "VISITED A HEALTH CARE PROVIDER": "The adverse event was serious enough to cause the consumer to visit a health care provider"
- "HOSPITALIZATION": "The consumer was hospitalized"
- "VISITED AN ER": "The consumer visited an ER"
- "LIFE THREATENING": "The adverse event was life threatening"
- "REQ. INTERVENTION TO PRVNT PERM. IMPRMNT.": "The adverse event caused an illness or injury serious enough to require intervention to prevent permanent impairment or disability"
- "SERIOUS INJURIES/ ILLNESS": "The adverse event caused serious injuries or illness"
- "DISABILITY": "The adverse event caused the permanent disability"
- "DEATH": "The adverse event was the death of the consumer"
- "NONE": "The outcome was not reported"
- "OTHER": "The outcome was not one of the specified types"
- "CONGENITAL ANOMALY": "The adverse event caused a birth defect in a baby"
- format:
- is_exact: true
- type: string
- type: array
- products:
- items:
- properties:
- industry_code:
- description: "The FDA industry code for the product. Results in this endpoint are generally limited to products tagged with industry codes related to human food and nutritional supplements or cosmetics."
- possible_values:
- type: one_of
- value:
- "2": "Whole Grain/Milled Grain Prod/Starch"
- "3": "Bakery Prod/Dough/Mix/Icing"
- "4": "Macaroni/Noodle Prod"
- "5": "Cereal Prep/Breakfast Food"
- "7": "Snack Food Item"
- "9": "Milk/Butter/Dried Milk Prod"
- "12": "Cheese/Cheese Prod"
- "13": "Ice Cream Prod"
- "14": "Filled Milk/Imit Milk Prod"
- "15": "Egg/Egg Prod"
- "16": "Fishery/Seafood Prod"
- "17": "Meat, Meat Products and Poultry"
- "18": "Vegetable Protein Prod"
- "20": "Fruit/Fruit Prod"
- "21": "Fruit/Fruit Prod"
- "22": "Fruit/Fruit Prod"
- "23": "Nuts/Edible Seed"
- "24": "Vegetables/Vegetable Products"
- "25": "Vegetables/Vegetable Products"
- "26": "Vegetable Oils"
- "27": "Dressing/Condiment"
- "28": "Spices, Flavors And Salts"
- "29": "Soft Drink/Water"
- "30": "Beverage Bases/Conc/Nectar"
- "31": "Coffee/Tea"
- "32": "Alcoholic Beverage"
- "33": "Candy W/O Choc/Special/Chew Gum"
- "34": "Choc/Cocoa Prod"
- "35": "Gelatin/Rennet/Pudding Mix/Pie Filling"
- "36": "Food Sweeteners (Nutritive)"
- "37": "Mult Food Dinner/Grav/Sauce/Special"
- "38": "Soup"
- "39": "Prep Salad Prod"
- "40": "Baby Food Prod"
- "41": "Dietary Conv Food/Meal Replacements"
- "42": "Edible Insects And Insect-derived Foods (Arthropods And Annelids)"
- "45": "Food Additives (Human Use)"
- "46": "Food Additives (Human Use)"
- "47": "Multiple Food Warehouses"
- "50": "Color Additiv Food/Drug/Cosmetic"
- "51": "Food Service/Conveyance"
- "52": "Miscellaneous Food Related Items"
- "53": "Cosmetics"
- "54": "Vit/Min/Prot/Unconv Diet(Human/Animal)"
- "55": "Pharm Necess & Ctnr For Drug/Bio"
- "56": "Antibiotics (Human/Animal)"
- "57": "Bio & Licensed In-Vivo & In-Vitro Diag"
- "59": "Multiple Drug Warehouses"
- "60": "Human and Animal Drugs"
- "61": "Human and Animal Drugs"
- "62": "Human and Animal Drugs"
- "63": "Human and Animal Drugs"
- "64": "Human and Animal Drugs"
- "65": "Human and Animal Drugs"
- "66": "Human and Animal Drugs"
- "67": "Type A Medicated Articles"
- "68": "Animal Devices and Diagnostic Products"
- "69": "Medicated Animal Feeds"
- "70": "Animal Food(Non-Medicated Feed and Feed Ingreds)"
- "71": "Byprodcts For Animal Foods"
- "72": "Pet/Laboratory Animal Food"
- "73": "Anesthesiology"
- "74": "Cardiovascular"
- "75": "Chemistry"
- "76": "Dental"
- "77": "Ear, Nose And Throat"
- "78": "Gastroenterological & Urological"
- "79": "General & Plastic Surgery"
- "80": "General Hospital/Personal Use"
- "81": "Hematology"
- "82": "Immunology"
- "83": "Microbiology"
- "84": "Neurological"
- "85": "Obstetrical & Gynecological"
- "86": "Ophthalmic"
- "87": "Orthopedic"
- "88": "Pathology"
- "89": "Physical Medicine"
- "90": "Radiological"
- "91": "Toxicology"
- "92": "Molecular Genetics"
- "94": "Ionizing Non-Medical Devices and Components"
- "95": "Light Emitting Non-Device Products"
- "96": "Radio Frequency Emitting Products"
- "97": "Sound Emitting Products"
- "98": "Tobacco Products"
- "99": "Bio/Anim Drug/Feed&Food/Med Dev/Rh Whse"
- format:
- is_exact: false
- type: string
- industry_name:
- description: "The FDA industry name associated with the product."
- format:
- is_exact: true
- possible_values:
- type: string
- name_brand:
- description: "The reported brand name of the product."
- format:
- is_exact: true
- possible_values:
- type: string
- role:
- description: "The reported role of the product in the adverse event report."
- possible_values:
- type: one_of
- value:
- "Suspect": "The product was suspected of causing the adverse event"
- "Concomitant": "The product was not suspected of causing the adverse event, but was being consumed or used at the same time when the adverse event started"
- "Not Available": "The suspected role of the product was not reported"
- format:
- is_exact: true
- type: string
- type: object
- type: array
- reactions:
- items:
- description: "MedDRA terms for the reactions. Note that these terms are encoded in British English. For instance, *diarrhea* is recorded as `DIARRHOEA`"
- possible_values:
- type: reference
- value:
- name: "MedDRA"
- link: "http://www.meddra.org/"
- format:
- is_exact: true
- type: string
- type: array
- report_number:
- description: "The report number."
- format:
- is_exact: false
- possible_values:
- type: string
- meta:
- format:
- type: object
- description: 'This section contains a disclaimer and license information. The field `last_updated` indicates when the data files were exported.'
- possible_values:
- properties:
- type: object
- disclaimer:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Important details notes about openFDA data and limitations of the dataset."
- possible_values:
- license:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Link to a web page with license terms that govern data within openFDA."
- possible_values:
- last_updated:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "The last date when this openFDA endpoint was updated. Note that this does not correspond to the most recent record for the endpoint or dataset. Rather, it is the last time the openFDA API was itself updated."
- possible_values:
- results:
- type: object
- properties:
- skip:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Offset (page) of results, defined by the `skip` [query parameter](/api/)."
- possible_values:
- limit:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Number of records in this return, defined by the `limit` [query parameter](/api/). If there is no `limit` parameter, the API returns one result."
- possible_values:
- total:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Total number of records matching the search criteria."
- possible_values:
-type: object
diff --git a/pages/api_endpoints/food/event/_infographics.yaml b/pages/api_endpoints/food/event/_infographics.yaml
deleted file mode 100644
index 74e02470..00000000
--- a/pages/api_endpoints/food/event/_infographics.yaml
+++ /dev/null
@@ -1,61 +0,0 @@
-- title: "Adverse food, dietary supplement, and cosmetic event reports since 2004"
- short: "Reports over time"
- description:
- - "This is the openFDA API endpoint for adverse food, dietary supplement, and cosmetic product events. An adverse event is submitted to the FDA to report adverse health effects and product complaints about food, dietary supplements, and cosmetics."
- countParam: "date_created"
- filters:
- - title: "All adverse event reports"
- searchParam: ""
- - title: "Involving nuts or edible seeds"
- searchParam: "products.industry_code:23"
- - title: "Reported directly by public"
- searchParam: "_missing_:companynumb"
- - title: "Resulting in a serious injury or illness"
- searchParam: 'outcomes:"serious+injuries"'
- filterByDate: true
- type: Line
-- title: "What types of products are reported?"
- short: "Product types"
- description:
- - "Certain product types have more adverse events associated with them than others. For example, nutritional and dietary supplements have more adverse event reports, partly because manufacturers and distributors are required to report them."
- countParam: "products.industry_name.exact"
- filters:
- - title: "All adverse event reports"
- searchParam: ""
- - title: "Resulting in a serious injury or illness"
- searchParam: 'outcomes:"serious+injuries"'
- - title: "Resulting in hair loss"
- searchParam: "reactions:alopecia"
- filterByDate: false
- type: Bar
-- title: "What outcomes are frequently reported?"
- short: "Reported outcomes"
- description:
- - "An adverse event may involve many reactions—like a rash, diarrhea, or more serious reactions. The ultimate outcome may be relatively benign—a non-serious injury—or it could be as serious as permanent impairment or death."
- countParam: "outcomes.exact"
- filters:
- - title: "All adverse event reports"
- searchParam: ""
- - title: "Product brand name includes the word *cheese*"
- searchParam: 'products.name_brand:"cheese"'
- - title: "Involving a cosmetic product"
- searchParam: "products.industry_code:53"
- filterByDate: false
- type: Bar
-- title: "What adverse reactions are frequently reported?"
- short: "Reported reactions"
- description:
- - "Adverse reactions can include symptoms like rashes, diarrhea, or headaches, or be much more serious. Use the buttons next to the chart to see how reported reactions vary with different search criteria."
- - "There is no certainty that a reported reaction was actually caused by consumption or use of a product—this data reports associations only."
- countParam: "consumer.age"
- filters:
- - title: "All adverse event reports"
- searchParam: ""
- - title: "Product brand name includes the word *cheese*"
- searchParam: 'products.name_brand:"cheese"'
- - title: "Involving a cosmetic product"
- searchParam: "products.industry_code:53"
- - title: "Involving a dietary supplement product"
- searchParam: "products.industry_code:54"
- filterByDate: false
- type: Bar
diff --git a/pages/api_endpoints/food/event/_meta.yaml b/pages/api_endpoints/food/event/_meta.yaml
deleted file mode 100644
index 179b8d8c..00000000
--- a/pages/api_endpoints/food/event/_meta.yaml
+++ /dev/null
@@ -1,11 +0,0 @@
-type: endpoint
-documentTitle: openFDA › Food › Adverse events API
-label: CAERS reports
-title: CAERS Reports
-description: An adverse event is submitted to the FDA to report adverse health effects and product complaints about foods, dietary supplements, and cosmetics.
-datasets:
- - CAERS
-path: /api_endpoints/food/event
-api_path: /food/event
-start: 20040101
-status: foodevent
diff --git a/pages/api_endpoints/food/event/index.jsx b/pages/api_endpoints/food/event/index.jsx
deleted file mode 100644
index a4be3bf3..00000000
--- a/pages/api_endpoints/food/event/index.jsx
+++ /dev/null
@@ -1,21 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-
-import content from './_content.yaml'
-import explorers from './_explorers.yaml'
-import infographics from './_infographics.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-import examples from './_examples.json'
-
-export default () => (
-
-)
diff --git a/pages/api_endpoints/food/index.jsx b/pages/api_endpoints/food/index.jsx
deleted file mode 100644
index 79d78606..00000000
--- a/pages/api_endpoints/food/index.jsx
+++ /dev/null
@@ -1,29 +0,0 @@
-import React from 'react'
-import Layout from '../../../components/Layout'
-import Hero from '../../../components/Hero'
-import EndpointBox from '../../../components/EndpointBox'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-
-
-
-
-
-)
\ No newline at end of file
diff --git a/pages/blog/2014-03-04-introducing-openfda/index.md b/pages/blog/2014-03-04-introducing-openfda/index.md
deleted file mode 100644
index 6a6c642c..00000000
--- a/pages/blog/2014-03-04-introducing-openfda/index.md
+++ /dev/null
@@ -1,14 +0,0 @@
----
-path: "/update/introducing-openfda"
-date: 2014-06-02 07:30:00
-title: "Introducing openFDA"
-authors:
- - "Taha Kass-Hout, MD, MS"
----
-Welcome to the new home of openFDA! We are incredibly excited to see so much interest in our work and hope that this site can be a valuable resource to those wishing to use public FDA data in both the public and private sector to spur innovation, further regulatory or scientific missions, educate the public, and save lives.
-
-Through openFDA, developers and researchers will have easy access to high-value FDA public data through RESTful APIs and structured file downloads. In short, our goal is to make it simple for an application, mobile, or web developer, or all stripes of researchers, to use data from FDA in their work. We've done an extensive amount of research both internally and with potential external developers to identify which datasets are both in demand and have a high barrier of entry. As a result, our initial pilot project will cover a number of datasets from various areas within FDA, defined into three broad focus areas: Adverse Events, Product Recalls, and Product Labeling. These API's won't have one-on-one matching to FDA's internal data organizational structure; rather, we intend to abstract on top of a myriad of datasets and provide appropriate metadata and identifiers when possible. Of course, we'll always make the raw source data available for people who prefer to work that way (and it's good to mention that we also will not be releasing any data that could potentially be used to identify individuals or other private information).
-
-The openFDA initiative is one part of the larger Office of Informatics and Technology Innovation roadmap. As part of my role as FDA's Chief Health Informatics Officer, I'm working to lead efforts to move FDA in to a cutting edge technology organization. You'll be hearing more about our other initiatives, including Cloud Computing, High Performance Computing, Next Generation Sequencing, and mobile-first deployment in the near future.
-
-As we work towards a release of openFDA we'll begin to share more about our work and how you can get involved. In the meantime, I suggest you sign up for our listserv ([on our home page](/)) to get the latest updates on the project. You can also reach our team at [open@fda.hhs.gov](mailto:open@fda.hhs.gov) if there is a unique partnership opportunity or other collaboration you wish to discuss.
diff --git a/pages/blog/2014-03-06-fda-path-forward-for-open-data-and-next-generation-sequencing/index.md b/pages/blog/2014-03-06-fda-path-forward-for-open-data-and-next-generation-sequencing/index.md
deleted file mode 100644
index 33c5ba3f..00000000
--- a/pages/blog/2014-03-06-fda-path-forward-for-open-data-and-next-generation-sequencing/index.md
+++ /dev/null
@@ -1,16 +0,0 @@
----
-path: "/update/fda-path-forward-for-open-data-and-next-generation-sequencing"
-date: 2014-03-06
-title: "FDA’s path forward for open data and Next Generation Sequencing"
-authors:
- - "Taha Kass-Hout, MD, MS"
----
-FDA has established an Office of Informatics and Technology Innovation (OITI) under the Chief Health Informatics Officer (CHIO) in order to spur technology innovation. The following presentation highlight two exciting initiatives within OITI:
-
- - OpenFDA: When implemented in September 2014, openFDA will offer easy access to FDA public data and highlight projects using these data in both the public and private sector to further regulatory or scientific missions, educate the public, and save lives.
-
- - Utility NGS (Next Generation Sequencing) in the Internet cloud: FDA is facing growing NGS needs for processing internal genome sequencing data as well as the NGS data from industry submissions. The NGS initiative is planning and developing a cloud-base Big Data platform and analytics for robust, secure and controlled data storage, analysis, and collaboration and potentially sharing public-access genome sequencing information.
-
-I gave this presentation last week at the 2014 Healthcare Information and Management Systems Society (HIMSS) Conference.
-
-
\ No newline at end of file
diff --git a/pages/blog/2014-06-01-ten-things-to-know-about-adverse-events/index.md b/pages/blog/2014-06-01-ten-things-to-know-about-adverse-events/index.md
deleted file mode 100644
index 88cd829b..00000000
--- a/pages/blog/2014-06-01-ten-things-to-know-about-adverse-events/index.md
+++ /dev/null
@@ -1,4995 +0,0 @@
----
-path: "/update/ten-things-to-know-about-adverse-events"
-date: 2014-06-02
-title: "Ten things to know about drug adverse events"
-authors:
- - "Sean Herron"
----
-We're incredibly excited by today's launch of openFDA, and in particular around the first publicly available dataset that has been published, [FDA's drug adverse reaction and medication error reports](/drug/event/). The dataset is huge, covering nearly 4 million records from 2004 to 2013. The openFDA team has put a ton of work in to creating a great developer experience around this dataset, and we hope you find it a valuable tool in creating application that help preserve and protect the public health.
-
-With such a large and complicated dataset, it's inevitable that things can be a bit overwhelming. Here's ten important things to consider that can hopefully help you use openFDA's first dataset more effectively:
-
-## 1. Start with the examples
-We've created a number of [fantastic interactive examples](/drug/event/) to help you get some perspective on the data at large. As you change settings on the example, you can both see a graph representing your query as well as see the API endpoint the graph is receiving data from. Lower on in the page, we provide a number of example scenarios with queries to help you learn how to perform different types of searches on the data.
-
-## 2. Know the limitations
-The data within the openFDA drug adverse event endpoint does have limitations. The reports within the dataset do not undergo extensive screening or validation. There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.
-
-As we rely on voluntary reports for adverse events, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event. Therefore, the data cannot be used to calculate the incidence of an adverse event or medication error in the U.S. population.
-
-Due to these limitations, it's best to consider drug adverse event reports as potential insights on trends rather than as cases from which you can determine the circumstances of an individual event.
-
-## 3. Know why the data is sometimes messy
-Due to the nature of how drug adverse events are collected, the data is sometimes a bit messy. You may encounter things you wouldn't expect to see or data that doesn't quite make sense. Reports are submitted to the FDA by consumers, industry, and medical professionals through a variety of means, including [MedWatch](http://www.fda.gov/Safety/MedWatch/default.htm), an online reporting portal. Some records even come in via paper and must be transcribed by hand.
-
-## 4. Make sure you check out the reference
-In addition to the main endpoint page, we provide an extensive [reference page](/drug/event/reference/) that gives you detailed field-by-field interpretations of what you can expect from each API call.
-
-## 5. Learn the Lucene query syntax
-openFDA queries are based on the Lucene query syntax. While we don't support the full range of Lucene queries (such as wildcard searches, which are resource-intensive for us to provide over such a large database), it can be useful to get a good understanding of how Lucene queries work. The interactive examples within the openFDA documentation provide a good overview of various scenarios that use different query constructs.
-
-## 6. Don't forget about `count`
-In addition to `search`, which return the entire contents of every adverse event report that matches your query, you can append `count` to your query URLs to get an overall count of the time something has occured. Take the following example:
-
-Reports containing a drug of the **nonsteroidal anti-inflammatory** pharmacologic class
-This query searches for records with the **nonsteroidal anti-inflammatory drug** phamacologic class.
-
-
-
-We can very easily find the top 1,000 reactions associated with this query by adding `count=patient.reaction.reactionmeddrapt.exact` to the query:
-
-
-
-## 7. Use the `openfda` fields!
-Perhaps the most innovative part of openFDA is the extensive work we've done to harmonize data and provide additional identifiers and information about products. A good number of entries in the drug adverse event dataset contain an `openfda` section, which is able to provide you a huge number of additional data fields, including:
-
-- `unii` [Unique Ingredient Identifier (UNII)](http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/default.htm)
-- [Structured Product Labeling](http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm), including:
- - `spl_id` Structured Product Label ID
- - `spl_set_id` Structured Product Label Set ID
-- `product_ndc` [National Drug Code](http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm)
-- `substance_name`
-- `rxcui` [RxNorm Concept Unique Identifier](https://www.nlm.nih.gov/research/umls/rxnorm/overview.html)
-- `product_type`
-- `pharm_class_cs` Pharmacologic Class Chemical Structure
-- `manufacturer_name`
-- `brand_name`
-- `route` Route of Administration
-- `nui` Numeric Unique Identifier
-- `pharm_class_moa` Pharmacologic Class Mechanism of Action
-- `package_ndc` Packaging [National Drug Code](http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm)
-- `pharm_class_epc` FDA Established Pharmacologic Class
-- `generic_name`
-- `application_number` [New Drug Application Number](http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm)
-
-## 8. Use `.exact` to count for phrases
-When using `count` in a query, it's important to include `.exact` at the end of the parameter (eg. `&count=patient.drug.openfda.pharm_class_epc.exact`). By including `.exact`, openFDA counts complete phrases rather than just individual words. Take the example of trying to find a list of the top pharmacologic classes associated with the patient reporting pain:
-
-Top reactions associated with "nonsteroidal anti-inflammatory drug"
-
-This query searches for the top 1,000 reactions associated with the "nonsteroidal anti-inflammatory drug" phamacologic class.
-
-
-
-If we remove the `.exact` from the end of the `count` parameter, however, the results look very different:
-
-Top reactions associated with "nonsteroidal anti-inflammatory drug"
-
-This query searches for the top 1,000 reactions associated with the "nonsteroidal anti-inflammatory drug" phamacologic class.
-
-
-
-In the second example, removing `.exact` meant that openFDA simply took a top list of words and counted them individually.
-
-## 9. Beware of `null` values
-Due to the nature of how we receive the data (and wanting to pass on the most accurate representation possible), fields which do not have a value either don't show up at all in a result or may appear with a `null` value. Your application logic should ensure that it can account for both.
-
-## 10. Watch for changes
-The drug adverse events API is openFDA's first product, and so will be evolving over time. We'll be announcing changes on the website and via the [listserv](https://list.nih.gov/cgi-bin/wa.exe?A0=openfda). Changes that are backwards-compatible will go directly in to the existing endpoint. If we must break compatibility, we'll issue a new version of the endpoint and deprecate the old one.
-
-We'll be adding additional data to this endpoint whenever a new [Quarterly Data File](http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm) is posted.
diff --git a/pages/blog/2014-06-02-openfda-innovative-initiative-opens-door-to-wealth-of-fda-publicly-available-data/index.md b/pages/blog/2014-06-02-openfda-innovative-initiative-opens-door-to-wealth-of-fda-publicly-available-data/index.md
deleted file mode 100644
index a49171bc..00000000
--- a/pages/blog/2014-06-02-openfda-innovative-initiative-opens-door-to-wealth-of-fda-publicly-available-data/index.md
+++ /dev/null
@@ -1,29 +0,0 @@
----
-path: "/update/openfda-innovative-initiative-opens-door-to-wealth-of-fda-publicly-available-data"
-date: 2014-06-02
-title: "OpenFDA: Innovative initiative opens door to wealth of FDA’s publicly available data"
-authors:
- - "Taha Kass-Hout, MD, MS"
----
-Today, I am pleased to announce the launch of [openFDA](https://open.fda.gov/), a new initiative from our Office of Informatics and Technology Innovation (OITI). OpenFDA is specifically designed to make it easier for developers, researchers, and the public to access and use the many large, important, health data sets collected by the agency.
-
-These publicly available data sets, once successfully integrated and analyzed, can provide knowledge and insights that cannot be gained from any other single source.
-
-Consider the 3 million plus reports of drug adverse reactions or medication errors submitted to FAERS, the FDA Adverse Event Reporting System (previously AERS), since 2004.
-Researchers, scientists, software developers, and other technically-focused individuals in both the private and public sectors have always been invited to mine that publicly available data set - and others - to educate consumers, which in turn can further our regulatory or scientific missions, and ultimately, save lives.
-
-But obtaining this information hasn’t always been easy.
-
-In the past, these vast datasets could be difficult for industry to access and to use. Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes.
-
-OpenFDA will make our publicly available data accessible in a structured, computer-readable format. It provides a "search-based" Application Programming Interface - the set of requirements that govern how one software application can talk to another – that makes it possible to find both structured and unstructured content online.
-
-Software developers can now build their own applications (such as a mobile phone app or an interactive website) that can quickly search, query or pull massive amounts of public information instantaneously and directly from FDA datasets in real time on an “as-needed” basis. Additionally, with this approach, applications can be built on one common platform that is free and open to use. Publicly available data provided through openFDA are in the public domain with a CC0 Public Domain Dedication.
-
-Drug adverse events is the first dataset – with reports submitted from 2004 through 2013 available now.
-
-Using this data, a mobile developer could create a search app for a smart phone, for example, a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug.
-
-As we focus on making existing public data more easily accessible, and providing appropriate documentation and examples to developers, it’s important to note that we will not release any data that could be used to identify individuals or reveal other private information.
-
-OpenFDA uses cutting-edge technologies deployed on FDA’s new Public Cloud Computing infrastructure enabled by OITI, and will serve as a pilot for how FDA can interact internally and with external stakeholders, spur innovation, and develop or use novel applications securely and efficiently. As we move forward with the early stages of openFDA, we will be listening closely to the public, researchers, industry and all other users for their feedback on how to make openFDA even more useful in promoting and protecting the public health.
\ No newline at end of file
diff --git a/pages/blog/2014-08-08-openfda-provides-ready-access-to-recall-data/index.md b/pages/blog/2014-08-08-openfda-provides-ready-access-to-recall-data/index.md
deleted file mode 100644
index dce7b013..00000000
--- a/pages/blog/2014-08-08-openfda-provides-ready-access-to-recall-data/index.md
+++ /dev/null
@@ -1,20 +0,0 @@
----
-path: "/update/openfda-provides-ready-access-to-recall-data"
-date: 2014-08-08
-title: "OpenFDA provides ready access to recall data"
-authors:
- - "Taha Kass-Hout, MD, MS"
----
-Every year, hundreds of human and animal foods, drugs, and medical devices are recalled from the market by manufacturers. These products may be labeled incorrectly or might pose health or safety issues. Most recalls are voluntary; in some cases they may be ordered by the U.S. Food and Drug Administration. Recalls are reported to the FDA, and compiled into its Recall Enterprise System, or RES. Every week, the FDA releases an enforcement report that catalogues these recalls. And now, for the first time, there is an Application Programming Interface (API) that offers developers and researchers direct access to all of the [drug,](http://open.fda.gov/drug/enforcement/) [device,](http://open.fda.gov/device/enforcement/) and [food enforcement reports,](http://open.fda.gov/food/enforcement/) dating back to 2004.
-
-The recalls in this dataset provide an illuminating window into both the safety of individual products and the safety of the marketplace at large. Recent reports have included such recalls as certain food [products](http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=V-075-2014&w=06252014&lang=eng) (for not containing the vitamins listed on the label), [a soba noodle salad](http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=F-2033-2014&w=06252014&lang=eng) (for containing unlisted soy ingredients), and a pain reliever (for not following laboratory testing requirements).
-
-At present, FDA provides various ways to access the recalls data, including an [RSS feed,](http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Recalls/rss.xml) a Flickr stream and a [search interface.](http://www.fda.gov/Safety/Recalls/default.htm) This new API supplements these sources as the first, and one-call, access to the entire enforcements archive. The hope is that this API will be useful to developers and researchers interested in FDA enforcement actions. Developers can now call into the API to add recalls data to mobile apps or consumer websites. And researchers could use the API to study individual manufacturers, product categories, or specific foods or drugs.
-
-The recalls database is the second dataset to be released on openFDA. Since openFDA debuted on June 2, 2014, the website has generated considerable interest. In the past five weeks, the site has had 34,000 sessions (two-thirds are new sessions) from 26,000 unique visitors worldwide that generated 80,000 page views.
-
-The [adverse events API](http://open.fda.gov/drug/event/) has been accessed by 18,000 Internet connected devices, with nearly 2.4 million API calls since the launch. At least one new website, http://www.researchae.com has been created to allow any user to submit queries on the adverse events data, and several other companies are integrating the data into their products and services. It is also being accessed by researchers inside and outside FDA and by journalists as well.
-
-More APIs will follow in the weeks ahead. OpenFDA is taking an agile (development in small chunks of iterations) approach in the creation and release of these APIs, with the objective of getting feedback from developers and researchers (as well as from industry and the public) at the GitHub and StackExchange forums that serve our project. We plan to incorporate some of the feedback into future iterations of the API. Accordingly, as we learn more about how the public might seek to use this data—and as a result of our agile and user-centered methodologies—the API structure may change in quite a bit in the coming months. It’s also important to note that this API, like all others on openFDA, are in beta and are not ready for clinical use. However, their contribution to FDA’s public health mission already now grows every day.
-
-(Cross-posted from the FDA blog, where this was originally published on July 16, 2014.)
\ No newline at end of file
diff --git a/pages/blog/2014-08-18-drug-product-labeling/index.md b/pages/blog/2014-08-18-drug-product-labeling/index.md
deleted file mode 100644
index 005ead7b..00000000
--- a/pages/blog/2014-08-18-drug-product-labeling/index.md
+++ /dev/null
@@ -1,28 +0,0 @@
----
-path: "/update/drug-product-labeling"
-date: 2014-08-18
-title: "Providing easy public access to prescription drug, over-the-counter drug, and biological product labeling"
-authors:
- - "Taha Kass-Hout, MD, MS"
----
-Every prescription drug (including biological drug products) approved by FDA for human use comes with FDA-approved labeling. The labeling contains information necessary to inform healthcare providers about the safe and effective use of the drug for its approved use(s). Once a prescription drug is approved, the labeling may be updated as new information becomes available, including, for example, new approved uses, new dosing recommendations, and new safety information. Thus, the approved labeling is a “living document” that changes over time to reflect increased knowledge about the safety and effectiveness of the drug.
-
-In some cases, the approved labeling for a prescription drug can be extensive, consisting of 20,000 words or more. This amount of information, while important to guide safe and effective use of the drug, can present formidable challenges. For example, it can be a daunting task to study more than one labeling to better understand a class of drugs, or to compare drugs, and to keep up with their regular changes. Although it has been publicly available for many years on FDA’s website, now this labeling is available on [openFDA](https://open.fda.gov) through an Application Programming Interface (API), which provides a way for software to interact directly with the data.
-
-For several years, the labeling have been posted publicly in Structured Product Labeling (SPL) format at [http://labels.fda.gov/](http://labels.fda.gov/). The SPL format enhances the ability to electronically access, search, and sort information in the labeling. The SPL files are also available at the National Library of Medicine’s DailyMed site and can be downloaded. We’ve created an API for the data to supplement (not replace) these resources, and to provide easy and timely access to changes or updates to the labeling.
-
-The openFDA drug product label API provides access to the data for nearly 60,000 prescription and over-the-counter (OTC) drug labeling. The prescription labeling includes sections such as the “Indications and Usage” and “Adverse Reactions” sections and the OTC labeling includes “Purpose” and “Uses” headings and so forth.
-
-This API can be used, for instance, to identify those medications that have a [Boxed Warning](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.57), to identify those medications that [have lactose](https://api.fda.gov/drug/label.json?search=effective_time:%5b20090601+TO+20140801%5d+AND+inactive_ingredient:lactose) listed as an inactive ingredient, to help identify those medications that have a known interaction with [grapefruit juice](http://www.fda.gov/forconsumers/consumerupdates/ucm292276.htm) (or other fruit juices), and to answer other queries.
-
-This API is just one more example of how openFDA is helping make publicly available data more accessible and useful. Since the first API for adverse events was posted on June 2, 2014, there have been more than 2.6 million API accesses with approximately 20,000 internet devices connected to the adverse events API alone, and more than 30,000 unique visitors to the site.
-
-It’s very important to note that the labeling for prescription drugs is proposed by the applicant, reviewed by FDA, and approved by FDA. The labeling for OTC medications is also either approved by FDA or must conform to applicable regulations that govern the content and format of OTC drug labeling that are not pre-approved by FDA.
-
-As a research and development project, openFDA is a work in progress (Beta phase), and we are eager to learn from the developer and research communities what possible uses these data might have. We are also interested in hearing from the community about other publicly available FDA datasets for which an API might prove useful.
-
-We are actively involved in the openFDA communities on GitHub and StackExchange, and encourage people interested in the project to participate in those communities. In addition to providing access to datasets, openFDA encourages innovative use of the agency’s publicly available data by highlighting potential data applications, and providing a place for community interaction with one another and with FDA domain experts.
-
-Over time, we hope that openFDA can become an important resource where developers, researchers, and the public at large will learn about the medications and other FDA-regulated products that protect and promote the health of Americans.
-
-(Cross-posted from the FDA blog, where this was published on August 18, 2014.)
\ No newline at end of file
diff --git a/pages/blog/2014-08-19-providing-easy-access-to-medical-device-reports/index.md b/pages/blog/2014-08-19-providing-easy-access-to-medical-device-reports/index.md
deleted file mode 100644
index 753c6532..00000000
--- a/pages/blog/2014-08-19-providing-easy-access-to-medical-device-reports/index.md
+++ /dev/null
@@ -1,23 +0,0 @@
----
-path: "/update/providing-easy-access-to-medical-device-reports"
-date: 2014-08-19
-title: "Providing easy access to medical device reports submitted to FDA since the early 1990s"
-authors:
- - "Taha Kass-Hout, MD, MS"
- - "Jeffrey Shuren, MD, JD"
----
-In addition to food and drugs, FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but occasionally they present a safety issue due to risks not identified in prior studies, a malfunction, a problem with manufacturing, or misuse.
-
-These incidents are collected in a publicly available FDA database called MAUDE - short for Manufacturer and User Facility Device Experience. As part of the openFDA project, there is now an Application Programming Interface (API) for this dataset, which provides a way for software to interact directly with the data. This API will allow developers and researchers to easily query thousands of reports dating back to the early 1990s.
-
-The API can be a powerful tool for generating hypotheses for further investigation or inquiry and can inform the development of safer, more effective technologies. For example, it can help identify new, potential safety signals as well as which classes of devices may be associated with particular adverse events.
-
-There are some necessary caveats to this API. The dataset is a record of reports submitted to FDA, and not a definitive accounting of every incident with every device. It may contain incomplete, inaccurate, unverified, or biased data. Thus, it cannot be used to determine incidence. And the appearance of a device in a report does not mean that cause-and-effect has been determined. Therefore, these data should be used in the context of other available information. It’s also important to note that the data made available under this initiative do not contain anything that potentially could be used to identify individuals or reveal other private information.
-
-This API is the latest in a series of openFDA releases that have made publicly available data more easily accessed and queried. We believe that these tools can be used by developers and researchers to make insights that fuel new, innovative products (such as mobile apps and websites), and that help protect and promote the public’s health. Over the last two months, openFDA has released several APIs related to drugs, food, and devices. Together, they help provide perspective on the work FDA is doing, and make the public health data the agency is developing easier to access and utilize.
-
-By design, openFDA is a research and development project that draws on community involvement. We are actively involved in the openFDA communities on GitHub and StackExchange, and encourage people interested in the project to participate in those communities. Together, we can make openFDA into a more useful, more powerful resource for the protection and advancement of the public health.
-
-In addition to providing datasets, openFDA encourages innovative use of the agency’s publicly available data by highlighting potential data applications, and providing a place for communities to interact with one another and with FDA domain experts.
-
-(Cross-posted from the FDA blog, where this was published on August 19, 2014.)
\ No newline at end of file
diff --git a/pages/blog/2015-05-11-an-open-challenge-to-tap-public-data/index.md b/pages/blog/2015-05-11-an-open-challenge-to-tap-public-data/index.md
deleted file mode 100644
index 9885483b..00000000
--- a/pages/blog/2015-05-11-an-open-challenge-to-tap-public-data/index.md
+++ /dev/null
@@ -1,90 +0,0 @@
----
-path: "/update/an-open-challenge-to-tap-public-data"
-date: 2015-05-11
-title: "Announcing the OpenFDA Developer Challenge - An open call to tap public data and improve public health"
-authors:
- - "Taha Kass-Hout, MD, MS"
----
-
-The FDA is launching its very first openFDA challenge to the developer community to take advantage of the following datasets and explore the range and extent of its impact for research.
-
-* **Adverse events data.** FDA’s publicly available drug adverse event and medication error reports, and medical device adverse event reports.
-
-* **Recalls data.** Enforcement report data, containing information gathered from public notices about certain recalls of FDA-regulated products.
-
-* **Labeling data.** Structured Product Labeling (SPL) data for FDA-regulated human prescription drug, OTC drug and biological product labeling.
-
-Below you can learn more about our challenges and how to get started. Choose to focus on Adverse Events & Spikes OR Structured Product Labeling & Language. Starting with Level 1, see how far you can get. For more detailed instructions, see “How to Participate” section below.
-
-### Background on openFDA
-
-OpenFDA is an Elasticsearch-basedAPI that serves public FDA data about drugs, devices, and foods. It was created by FDA’s Chief Health Informatics officer, Taha Kass-Hout, MD, MS and launched in Beta mode in June 2014 to facilitate easy access to public data, to ensure the security of public FDA data, and ultimately to educate the public and save lives.
-
-The concept is to index high-value public-access data, format and document that data in developer and consumer-friendly standards, and make it available via a public-access portal that enables developers to quickly and easily use it in applications. Learn more about openFDA.
-
-### Research challenge
-
-_**Option 1: Adverse Events & Spikes**_
-
-_Start with level 1 and see how far you can get._
-
-* **Level 1: Identify it.** Find a spike for a given drug query in the Adverse Events dataset and attempt explain it. For example, was there a recall or an enforcement report issued? Try bucketing by the following variables over time: weight, gender, or drug pairs (further broken down by drug characterization).
-
-* **Level 2: Normalize it.** Using publicly-available health-related data (medical care claims, discharge data, emergency room data) as a normalization method — how does the spike in the adverse event series change, if at all?
-
-* **Level 3: Automate it.** Is there an algorithm that could be used to automatically identify such spikes?
-
-_**Option 2: Structured Product Labeling & Language**_
-
-_Start with level 1 and see how far you can get._
-
-* **Level 1: Visualize it.** Create a word cloud visualization of black box warnings on /drug/label. This will allow you to explore the strength of tone used and variability across warnings.
-
-* **Level 2: Model it.** Develop a language model to categorize the language in the warning sections of SPLs as mild, moderate or severe. Note: This model does not have to be exhaustive. Be sure to give each SPL a tonal score based on the language model you’ve created.
-
-* **Level 3: Analyze it.** Based on openFDA section, does your language model change across drug classes? (e.g., do HIV drugs or anti-inflammatories ‘speak’ differently?)
-
-### How to Participate
-
-1. Choose option you’re most interested in, from above.
-1. Tweet @openFDA with the challenge you’ll be working on, using #openFDAchallenge. To level up your competition, invite your friends.
-1. Start working on a solution to the challenge either by flying solo or with a team.
-1. When you’ve got something to show, submit a link to your project on the openFDA subreddit, and vote or comment on your favorites.
-
-That’s it!
-
-_Remember: You can always post questions to StackExchange about the challenge or the data, using the tag: openFDA_
-
-### Frequently Asked Questions
-
-**Question**: Why is FDA offering openFDA challenges?
-
-**Answer**:
-These challenges are meant to be open-ended and to spark creative responses by two communities: the community that develops apps or software that use openFDA, and the community that does research using openFDA.
-
-**Question**: Who is expected to benefit from these challenges?
-
-**Answer**:
-Although the direct beneficiaries are expected to be the public, it’s possible that an outcome could be useful for FDA work. For example, the community initially developed the code to connect the R library (a group of open source statistical analysis packages) to openFDA; we found it so useful that we provided additional links and functionality for using R on openFDA data, which can be found at Convenient access to the OpenFDA API.
-
-**Question**: What do you see as the benefits for researchers and developers participating in the challenges? Are there any rewards you are offering to those who do get involved?
-
-**Answer**:
-FDA is issuing the challenge to encourage creative use of openFDA, including uses we haven’t thought of. So far, the community has already contributed more than seven major changes to openFDA's platform open source code, demonstrating that the top developers are out in the public.
-Contributors receive recognition by the open source community, whether or not their contributions become formally integrated into openFDA.
-
-**Question**: How do the challenges reflect the sorts of new directions that are now possible with openFDA's APIs?
-
-**Answer**:
-There are two types of challenges: enhancing the data and integrating the platform with other sources.
-The specific options are options meant to spark ideas. As stated above, FDA expects that there are people with great ideas we didn’t think of for using openFDA. The example options also don’t mean anything about FDA’s regulatory or research priorities, or FDA’s ideas about the public’s priorities for using openFDA.
-
-**Question**: Are the challenges open-ended, i.e., is there a deadline? How long do you expect them to take for participants to start submitting?
-
-**Answer**:
-The openFDA developer challenges are meant to be open-ended and to spark creative responses, as explained above. Being open-ended, there is no set beginning or ending date. The responses are expected to appear in openFDA subreddit whenever responders feel ready. In the meantime, questions or discussions may appear in the openFDA section of StackExchange.
-
-**Question**: What’s next?
-
-**Answer**:
-What comes next depends on all of you! The larger community will comment and vote on the challenge responses as they get posted in openFDA subreddit. FDA will evaluate them and decide what to do next. Meanwhile, other members of the community may also decide to take further action on any of the challenges.
diff --git a/pages/blog/2015-07-17-first-year-in-perspective/index.md b/pages/blog/2015-07-17-first-year-in-perspective/index.md
deleted file mode 100644
index ea3124fa..00000000
--- a/pages/blog/2015-07-17-first-year-in-perspective/index.md
+++ /dev/null
@@ -1,12 +0,0 @@
----
-path: "/update/first-year-in-perspective"
-date: 2015-07-20
-title: "OpenFDA: The First Year in Perspective"
-authors:
- - "Taha Kass-Hout, MD, MS"
----
-On May 22, 2015, Dr. Taha Kass-Hout gave an update on the openFDA project at the Big Data in Biomedicine conference at Stanford University.
-
-His talk, coming a year after the first APIs were launched at openFDA, covers the progress that has been made with the project so far. Based on the three pillars of Open Data, Open Source, and Open Community, the openFDA project has spawned dozens of apps, thousands of community members, and millions of API calls.
-
-
\ No newline at end of file
diff --git a/pages/blog/2015-07-23-drilling-into-the-details/index.md b/pages/blog/2015-07-23-drilling-into-the-details/index.md
deleted file mode 100644
index cefad1b7..00000000
--- a/pages/blog/2015-07-23-drilling-into-the-details/index.md
+++ /dev/null
@@ -1,16 +0,0 @@
----
-path: "/update/drilling-into-the-details"
-date: 2015-07-23
-title: "OpenFDA: Drilling Into The Details"
-authors:
- - "OpenFDA Team"
----
-By design, openFDA is an open system. It is built using open standards, uses open source software, and the code itself is publicly available at Github. Given the unique nature of this approach, the technical details of this system may be of interest. Accordingly, for those curious about the structure and design of the openFDA platform, we’ve created two documents that drill into the details of the architecture and technical design of openFDA, including the various software and technologies throughout the system, and how that system can be leveraged for insights. These documents are available here for download as PDFs.
-
-The first document explains in detail the technical architecture, data structure, data sources, data processing and harmonization, and software stack:
-
- * Download openFDA Technologies Whitepaper
-
-The second document offers one case study in how openFDA data can be leveraged to generate insights. It walks through a project that transparently demonstrates JSON URL queries and uses R software to visualize and explore openFDA adverse events data. The particular example looks at an apparent association between “aspirin” and “flushing” and how the data can be misleading:
-
- * Download openFDA Analysis Example Whitepaper
\ No newline at end of file
diff --git a/pages/blog/2015-08-06-new-release-coming-soon/index.md b/pages/blog/2015-08-06-new-release-coming-soon/index.md
deleted file mode 100644
index 4c7f6c9b..00000000
--- a/pages/blog/2015-08-06-new-release-coming-soon/index.md
+++ /dev/null
@@ -1,26 +0,0 @@
----
-path: "/update/new-release-coming-soon"
-date: 2015-08-06
-title: "Mark your calendars: A new release coming soon from openFDA"
-authors:
- - "OpenFDA Team"
----
-The FDA created openFDA to make their public information about food, drugs, and devices more accessible and useful to developers. To that end, the FDA has made a continuous effort to better understand the needs of the developer community and build on existing resources. Improvements to-date have consisted of making more data available, hardening the system, and making it easier and faster to access the data itself.
-
-At the end of August 2015, FDA plans to make more datasets from the Center for Devices and Radiological Health (CDRH) available to the public to show the “Total Product Life Cycle” of medical devices and provide useful context. As with other openFDA efforts, this data will be released through a new application program interface (API) designed to be easily integrated by developers and researchers for the public’s benefit. It’s worth noting that these datasets, in addition to device adverse events reports currently available in openFDA, will have device-oriented harmonization.
-
-These new datasets include:
-
- 1. Product Classification - A list of medical device types with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information.
-
- 2. Registration and Device Listing - A list of all medical device manufacturers registered with FDA and medical devices listed with FDA.
-
- 3. Medical Device Recalls – An expanded set of data Medical Device Recall data, compared to what is currently in openFDA. It will include recalls classified since November 1, 2002, and more information on each recall. Recalls occur when a medical device is violative and recall classification is used to indicate the risk to health.
-
- 4. 510k – The list of devices that FDA found are substantially equivalent to a legally marketed device that is not subject to premarket approval, and are cleared for commercial distribution in the US.
-
- 5. PMA – The list of devices approved for marketing through the FDA Premarket Approval (PMA) process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices.
-
-For full access and insights into what can be done with these datasets and the new API, check back in at the end of the month.
-
-
diff --git a/pages/blog/2015-08-31-openfda-unveils-cache-of-medical-device-data/index.md b/pages/blog/2015-08-31-openfda-unveils-cache-of-medical-device-data/index.md
deleted file mode 100644
index 4b06918c..00000000
--- a/pages/blog/2015-08-31-openfda-unveils-cache-of-medical-device-data/index.md
+++ /dev/null
@@ -1,26 +0,0 @@
----
-path: "/update/openfda-unveils-cache-of-medical-device-data"
-date: 2015-08-31
-title: "OpenFDA Unveils Cache of Medical Device Data"
-authors:
- - "Taha Kass-Hout, MD, MS"
- - "Roselie A. Bright, ScD, MS"
- - "Ann Ferriter"
----
-OpenFDA is releasing information on medical devices that could spur innovation and advance scientific research.
-
-OpenFDA’s Application Programming Interface (API) expands the previous openFDA resources about medical device-related adverse events and recalls by incorporating information from the total medical device product life cycle. This includes current data on device classification (6000 records), 24,000 registrations of device companies and establishments, and the companies’ listings of over 100,000 devices. Data since 1976 on 30,000 device approvals and approval supplements, and 141,000 device clearance decisions (510(k) and de novo types) are now on openFDA. In addition, more details about device recalls (9,500 records going back to 2002) and adverse event reports (4.2 million records since 1991) were added. Although this information has been available on our public databases for many years, now developers can more easily access and use the data.
-
-The flexible openFDA interface functions well even when greater demands are made on it and is designed on a common platform so developers can harmonize and integrate data from various sources and build their own applications. For example, they could develop a smartphone app to determine all the recalls associated with a particular class of devices or find all companies that manufacture certain types of devices.
-
-There are some important safeguards. For example, the information doesn’t contain anything that potentially could be used to identify individuals or reveal confidential commercial information.
-
-Everything available in these datasets should be used in the appropriate context. FDA has harmonized the data, but there may be instances when a query does not return a full and complete result. For example, if the name of a manufacturer is listed with different spellings, some variations may not be captured in the result.
-
-Some datasets are snapshots in time. For example, the 510(k) data shows who submitted the 510(k), the device name and other information at the time of clearance. In addition, the types of information that FDA has collected has changed over the years, which can make it difficult to look at data over time. Also, the data may not have enough information to establish cause and effect, incidence, nor prevalence.
-
-Part of openFDA’s mission is to engage the public to advance the understanding and use of the data. This API is the latest in a series of openFDA releases that have made publicly available data more easily accessed and queried. We believe these tools can be used by developers and researchers to make insights that fuel new, innovative products that help protect and promote public health.
-
-By design, openFDA is a research and development project that draws on community involvement. We are actively involved in the openFDA communities on GitHub and StackExchange, and we encourage everyone to participate in those communities.
-
-Over the last year, there have been dozens of tools created using openFDA resources. We hope this enhanced devices data will be put to similar use. Together, we can make openFDA an even more useful, more powerful resource for all.
\ No newline at end of file
diff --git a/pages/blog/2015-12-23-openfda-now-allows-direct-downloads-of-data/index.md b/pages/blog/2015-12-23-openfda-now-allows-direct-downloads-of-data/index.md
deleted file mode 100644
index 7ea09f73..00000000
--- a/pages/blog/2015-12-23-openfda-now-allows-direct-downloads-of-data/index.md
+++ /dev/null
@@ -1,24 +0,0 @@
----
-path: "/update/openfda-now-allows-direct-downloads-of-data"
-date: 2015-12-23
-title: "OpenFDA Now Allows Direct Downloads of Data"
-authors:
- - "OpenFDA Team"
----
-Since its launch in June 2014, the impetus for openFDA has been to make it easier to get access to publicly available FDA data. FDA’s goal is to make it simple for an application, mobile device, web developer, or researcher to use data from FDA.
-
-To date, one major focus of this project has been to provide high-value APIs (short for Application Programming Interfaces), which make it easy for developers and researchers to query and build upon data related to drug adverse events, drug labeling, medical devices (including adverse events and device registration), and food recalls.
-
-All along, though, we have heard from some users who requested direct access to the data, by download. Today, we’re pleased to make that possible, by adding download functionality to openFDA that allows offline access to the JSON data served by the API.
-
-Two particulars here. First, the data available for download are the same datasets previously available at openFDA. The JSON schema used for the downloads is exactly the same as the output you currently get from the API.
-
-Second, the entire dataset is 23GB compressed, and expands to about 100 GB – so please take necessary precautions before downloading. The download function is not intended to be a primary use case for most openFDA visitors; OpenFDA is designed primarily for queries against our powerful search API. But some applications may require all the data available in a dataset (device recalls, for instance), or exceed the query limits or result limit (5000 records per query) that allow us to promote equitable access and manage load on the system. Today’s addition of downloads serves those needs.
-
-There are two things you should know about these downloads:
-
-* Downloads are broken into parts. Some endpoints have millions of records. For those endpoints, the data are broken up into many small parts. So while some endpoints have all their data available in a single file, others have dozens of files. Each file is a zipped JSON file.
-
-* To keep your downloaded data up to date, you need to re-download the data every time it is updated. Every time an endpoint is updated (which happens on a regular basis; the openFDA status page stays current with the latest update date), it is possible that every record has changed, due to corrections or enhancements. That means that you cannot simply download “new” files to keep your downloaded version up to date. You need to download all available data files for the endpoint of interest.
-
-In the months ahead we will continue to improve openFDA to reflect the needs of our users, community, and the public at large. If you have ideas, please share with the community at GitHub and StackExchange. If your questions or ideas aren’t already there, please tell us what you think! You can also follow the project on Twitter at @openFDA or reach our team at open@fda.hhs.gov.
diff --git a/pages/blog/_template.jsx b/pages/blog/_template.jsx
deleted file mode 100644
index b9e477f8..00000000
--- a/pages/blog/_template.jsx
+++ /dev/null
@@ -1,2 +0,0 @@
-import React from 'react'
-export default (props) => props.children
diff --git a/pages/community/_apps.yaml b/pages/community/_apps.yaml
deleted file mode 100644
index a8f1e869..00000000
--- a/pages/community/_apps.yaml
+++ /dev/null
@@ -1,22 +0,0 @@
-- title: 'Anti-Epileptic Drug Search'
- url: 'http://pool3.18f.flexion.us/'
-- title: 'Drug Reaction Research Report'
- url: 'http://openfda.ventera.com/web/#/'
-- title: 'FDA Enforcement Reports'
- url: 'https://truetandem-gsa.appspot.com/'
-- title: 'Find recalled food products in your state'
- url: 'http://esridc.github.io/openfda'
-- title: 'Food Recall Impact'
- url: 'http://agile-bpa.elasticbeanstalk.com/'
-- title: 'Local Alternatives'
- url: 'https://devis18f.herokuapp.com/'
-- title: 'MedCheck'
- url: 'https://medcheck.octoconsulting.com/#/'
-- title: 'Rxpectations'
- url: 'http://rxpectations.herokuapp.com/'
-- title: 'Search Food Recalls'
- url: 'https://acumen-gsa-prototype.herokuapp.com/#/search'
-- title: 'ResearchAE'
- url: 'http://www.researchae.com/'
-- title: 'KnowRx'
- url: 'https://play.google.com/store/apps/details?id=knowrx.knowrx'
diff --git a/pages/community/index.jsx b/pages/community/index.jsx
deleted file mode 100644
index 3c84b67c..00000000
--- a/pages/community/index.jsx
+++ /dev/null
@@ -1,42 +0,0 @@
-import React from 'react'
-import marked from 'marked'
-
-import Hero from '../../components/Hero'
-import Layout from '../../components/Layout'
-import tools from './_apps.yaml'
-
-const aCx: string = 'clr-gray font-size-4 weight-400 t-pad-t-2 t-pad-b-2 block reading-width t-marg-b-2'
-const linkCx: string = 'clr-gray b-b-1 marg-b-1'
-const disclaimer: string = 'http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm'
-export default () => (
-
-
-
-
-
-
-
-
-
-)
diff --git a/pages/data.json b/pages/data.json
deleted file mode 100644
index 553716a2..00000000
--- a/pages/data.json
+++ /dev/null
@@ -1,3351 +0,0 @@
-{
- "conformsTo": "https://project-open-data.cio.gov/v1.1/schema",
- "as_of_date": "Tuesday, August 18, 2015",
- "dataset": [
- {
- "accessLevel": "public",
- "bureauCode": [
- "009:10"
- ],
- "contactPoint": {
- "fn": "openFDA",
- "hasEmail": "mailto:open@fda.hhs.gov"
- },
- "description": "This list includes human and pet food subject to recall in the United States since January 2009 related to peanut products distributed by Peanut Corporation of America. ",
- "distribution": [
- {
- "downloadURL": "http://www.accessdata.fda.gov/scripts/peanutbutterrecall/PeanutButterProducts2009.xml",
- "mediaType": "application/xml",
- "accessURL": "http://www.accessdata.fda.gov/scripts/peanutbutterrecall/PeanutButterProducts2009.xml",
- "downloadURL": "http://www.accessdata.fda.gov/scripts/peanutbutterrecall/PeanutButterProducts2009.xml",
- "format": "XML"
- }
- ],
- "accrualPeriodicity": "irregular",
- "identifier": "5d4b366c-07ca-4358-a783-01aa2fe59684",
- "keyword": [
- "recalls"
- ],
- "modified": "1900-01-01",
- "programCode": [
- "009:001"
- ],
- "publisher": {
- "name": "Office of Regulatory Affairs",
- "subOrganizationOf": {
- "name": "U.S. Food and Drug Administration"
- }
- },
- "title": "Peanut Product Recalls",
- "landingPage": "http://www.accessdata.fda.gov/scripts/peanutbutterrecall/PeanutButterProducts2009.xml"
- },
- {
- "accessLevel": "public",
- "bureauCode": [
- "009:10"
- ],
- "contactPoint": {
- "fn": "openFDA",
- "hasEmail": "mailto:open@fda.hhs.gov"
- },
- "description": "This list includes food subject to recall in the United States since March 2009 related to pistachios distributed by Setton Pistachio of Terra Bella, Inc. The FDA has completed its inspection of Salmonella contamination in pistachios and pistachio products involved in this recall. ",
- "distribution": [
- {
- "downloadURL": "http://www.accessdata.fda.gov/scripts/pistachiorecall/Pistachio2009.xml",
- "mediaType": "application/xml",
- "accessURL": "http://www.accessdata.fda.gov/scripts/pistachiorecall/Pistachio2009.xml",
- "downloadURL": "http://www.accessdata.fda.gov/scripts/pistachiorecall/Pistachio2009.xml",
- "format": "XML"
- }
- ],
- "accrualPeriodicity": "irregular",
- "identifier": "8acf8bd4-3c2b-4697-a2be-3d5006fbfc91",
- "keyword": [
- "ora"
- ],
- "modified": "1900-01-01",
- "programCode": [
- "009:001"
- ],
- "publisher": {
- "name": "Office of Regulatory Affairs",
- "subOrganizationOf": {
- "name": "U.S. Food and Drug Administration"
- }
- },
- "title": "Pistachio Product Recalls",
- "landingPage": "http://www.accessdata.fda.gov/scripts/pistachiorecall/Pistachio2009.xml"
- },
- {
- "accessLevel": "public",
- "bureauCode": [
- "009:10"
- ],
- "contactPoint": {
- "fn": "openFDA",
- "hasEmail": "mailto:open@fda.hhs.gov"
- },
- "description": "This list includes products subject to recall in the United States since February 2010 related to hydrolyzed vegetable protein (HVP) paste and powder distributed by Basic Food Flavors, Inc. HVP is a flavor enhancer used in a wide variety of processed food products such as soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips, and dressings. ",
- "distribution": [
- {
- "downloadURL": "http://www.accessdata.fda.gov/scripts/HVPCP/HydrolyzedVegetableProteinProductsList2010.xml",
- "mediaType": "application/xml",
- "accessURL": "http://www.accessdata.fda.gov/scripts/HVPCP/HydrolyzedVegetableProteinProductsList2010.xml",
- "downloadURL": "http://www.accessdata.fda.gov/scripts/HVPCP/HydrolyzedVegetableProteinProductsList2010.xml",
- "format": "XML"
- }
- ],
- "accrualPeriodicity": "irregular",
- "identifier": "0a235bac-418f-4fa9-81b7-1af3259a54b1",
- "keyword": [
- "recalls"
- ],
- "modified": "1900-01-01",
- "programCode": [
- "009:001"
- ],
- "publisher": {
- "name": "Office of Regulatory Affairs",
- "subOrganizationOf": {
- "name": "U.S. Food and Drug Administration"
- }
- },
- "title": "Hydrolyzed Vegetable Protein Containing Products Recalls",
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- {
- "description": "Website is still under development, not yet published to the public. Pre-Production L is: http://accessdata-preprod.fda.gov/scripts/hphc/",
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- "accessLevel": "public",
- "bureauCode": [
- "009:10"
- ],
- "contactPoint": {
- "fn": "FDA Enterprise Data Inventory",
- "hasEmail": "mailto:FDA_Enterprise_Data_Inventory@fda.hhs.gov"
- },
- "description": "Contains data for FDA pet food recalls since January 1, 2006.",
- "distribution": [
- {
- "downloadURL": "http://www.fda.gov/AboutFDA/Transparency/OpenGovernment/ucm225435.htm",
- "mediaType": "application/unknown",
- "accessURL": "http://www.fda.gov/AboutFDA/Transparency/OpenGovernment/ucm225435.htm",
- "downloadURL": "http://www.fda.gov/AboutFDA/Transparency/OpenGovernment/ucm225435.htm",
- "format": "application/unknown"
- }
- ],
- "identifier": "6e4c0c94-6b71-49f8-b551-c70a9070867e",
- "keyword": [
- "health",
- "market",
- "notifications",
- "pet food",
- "recalls",
- "safety"
- ],
- "modified": "2010-10-01",
- "programCode": [
- "009:000"
- ],
- "publisher": {
- "name": "Food and Drug Administration",
- "subOrganizationOf": {
- "name": "U.S. Food and Drug Administration"
- }
- },
- "title": "FDA Pet Health and Safety Widget",
- "landingPage": "http://www.fda.gov/AboutFDA/Transparency/OpenGovernment/ucm225435.htm"
- },
- {
- "accessLevel": "public",
- "bureauCode": [
- "009:10"
- ],
- "contactPoint": {
- "fn": "FDA Enterprise Data Inventory",
- "hasEmail": "mailto:FDA_Enterprise_Data_Inventory@fda.hhs.gov"
- },
- "description": "Contains data for the FDA Plainview Milk Cooperative Ingredient Recall since June 2009.",
- "distribution": [
- {
- "downloadURL": "http://www.accessdata.fda.gov/scripts/Milk/MilkRecallProducts2009.xls",
- "mediaType": "application/vnd.ms-excel",
- "accessURL": "http://www.accessdata.fda.gov/scripts/Milk/MilkRecallProducts2009.xls",
- "downloadURL": "http://www.accessdata.fda.gov/scripts/Milk/MilkRecallProducts2009.xls",
- "format": "Excel"
- }
- ],
- "identifier": "5d970911-f35f-4514-9ddf-b20bc32790ff",
- "keyword": [
- "community health",
- "food",
- "health",
- "market",
- "milk",
- "notifications",
- "recalls",
- "safety"
- ],
- "modified": "2010-10-01",
- "programCode": [
- "009:000"
- ],
- "publisher": {
- "name": "Food and Drug Administration",
- "subOrganizationOf": {
- "name": "U.S. Food and Drug Administration"
- }
- },
- "title": "FDA Plainview Milk Cooperative Ingredient Recall",
- "landingPage": "http://www.fda.gov/AboutFDA/Transparency/OpenGovernment/ucm225440.htm"
- },
- {
- "accessLevel": "public",
- "bureauCode": [
- "009:10"
- ],
- "contactPoint": {
- "fn": "FDA Enterprise Data Inventory",
- "hasEmail": "mailto:FDA_Enterprise_Data_Inventory@fda.hhs.gov"
- },
- "description": "Contains data for FDA pistachio product recalls since March 2009.",
- "distribution": [
- {
- "downloadURL": "http://www.accessdata.fda.gov/scripts/pistachiorecall/Pistachio2009.xls",
- "mediaType": "application/vnd.ms-excel",
- "accessURL": "http://www.accessdata.fda.gov/scripts/pistachiorecall/Pistachio2009.xls",
- "downloadURL": "http://www.accessdata.fda.gov/scripts/pistachiorecall/Pistachio2009.xls",
- "format": "Excel"
- }
- ],
- "identifier": "a501b289-fe9f-4c20-980f-f95f34c81f30",
- "keyword": [
- "community health",
- "food",
- "health",
- "market",
- "notifications",
- "pistachio",
- "recalls",
- "safety"
- ],
- "modified": "2010-10-01",
- "programCode": [
- "009:000"
- ],
- "publisher": {
- "name": "Food and Drug Administration",
- "subOrganizationOf": {
- "name": "U.S. Food and Drug Administration"
- }
- },
- "title": "FDA Pistachio Product Recalls",
- "landingPage": "http://www.fda.gov/AboutFDA/Transparency/OpenGovernment/ucm225438.htm"
- },
- {
- "accessLevel": "public",
- "bureauCode": [
- "009:10"
- ],
- "contactPoint": {
- "fn": "FDA Enterprise Data Inventory",
- "hasEmail": "mailto:FDA_Enterprise_Data_Inventory@fda.hhs.gov"
- },
- "description": "Contains data for FDA shell egg recalls.",
- "temporal": "2010-01-01/2010-12-31",
- "distribution": [
- {
- "downloadURL": "http://www.accessdata.fda.gov/scripts/shelleggsrecall/ShellEggsRecallList2010.xls",
- "mediaType": "application/vnd.ms-excel",
- "accessURL": "http://www.accessdata.fda.gov/scripts/shelleggsrecall/ShellEggsRecallList2010.xls",
- "downloadURL": "http://www.accessdata.fda.gov/scripts/shelleggsrecall/ShellEggsRecallList2010.xls",
- "format": "Excel"
- }
- ],
- "identifier": "dc522ec9-a996-440b-b94e-972136ab80c0",
- "keyword": [
- "community health",
- "food",
- "health",
- "market",
- "notifications",
- "recalls",
- "safety"
- ],
- "modified": "2010-10-01",
- "programCode": [
- "009:000"
- ],
- "publisher": {
- "name": "Food and Drug Administration",
- "subOrganizationOf": {
- "name": "U.S. Food and Drug Administration"
- }
- },
- "title": "FDA Shell Egg Recalls",
- "landingPage": "http://www.fda.gov/AboutFDA/Transparency/OpenGovernment/ucm225434.htm"
- },
- {
- "accessLevel": "public",
- "bureauCode": [
- "009:10"
- ],
- "contactPoint": {
- "fn": "FDA Enterprise Data Inventory",
- "hasEmail": "mailto:FDA_Enterprise_Data_Inventory@fda.hhs.gov"
- },
- "description": "Contains data for FDA Hydrolyzed Vegetable Protein (HVP) Containing Products recalls since February, 2010.",
- "distribution": [
- {
- "downloadURL": "http://www.accessdata.fda.gov/scripts/HVPCP/HydrolyzedVegetableProteinProductsList2010.xls",
- "mediaType": "application/vnd.ms-excel",
- "accessURL": "http://www.accessdata.fda.gov/scripts/HVPCP/HydrolyzedVegetableProteinProductsList2010.xls",
- "downloadURL": "http://www.accessdata.fda.gov/scripts/HVPCP/HydrolyzedVegetableProteinProductsList2010.xls",
- "format": "Excel"
- }
- ],
- "identifier": "97f8facf-a2b8-47f0-847b-d7e7bc165c09",
- "keyword": [
- "community health",
- "health",
- "hvp",
- "hydrolyzed vegetable protein",
- "market",
- "notifications",
- "recalls",
- "safety"
- ],
- "modified": "2010-10-01",
- "programCode": [
- "009:000"
- ],
- "publisher": {
- "name": "Food and Drug Administration",
- "subOrganizationOf": {
- "name": "U.S. Food and Drug Administration"
- }
- },
- "title": "FDA Hydrolyzed Vegetable Protein (HVP) Containing Products Recalls",
- "landingPage": "http://www.fda.gov/AboutFDA/Transparency/OpenGovernment/ucm225437.htm"
- }
- ]
-}
diff --git a/pages/data/510k/_meta.yaml b/pages/data/510k/_meta.yaml
deleted file mode 100644
index 3411ebef..00000000
--- a/pages/data/510k/_meta.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › 510(k) Clearances'
-crumbs:
- - openFDA
- - Datasets
- - 510(k) Clearances
-title: '510(k) Clearances'
-description: 'A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).'
-source:
- name: '510(k)'
- nameLong: '510(k) Clearances'
- link: 'http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm'
- linkDownload: 'http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start: '1976'
- current: Current
- delay:
- frequency: 'Monthly'
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - "A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements."
\ No newline at end of file
diff --git a/pages/data/510k/index.jsx b/pages/data/510k/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/510k/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/_content.yaml b/pages/data/_content.yaml
deleted file mode 100644
index 7bc88afd..00000000
--- a/pages/data/_content.yaml
+++ /dev/null
@@ -1,25 +0,0 @@
--
- url: /data/faers/
- title: FAERS
- description:
- - The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.
- - See the [FAERS web site](http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm) for download information.
--
- url: /data/maude/
- title: MAUDE
- description:
- - FDA dataset that contains medical device adverse event reports submitted by mandatory reporters—manufacturers, importers and device user facilities—and voluntary reporters such as health care professionals, patients, and consumers.
- - See the [MAUDE web site](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) for download information.
--
- url: /data/res/
- title: RES
- description:
- - The Recall Enterprise System (RES) is an electronic data system used by FDA recall personnel to submit, update, classify, and terminate recalls.
- - See the [RES web site](http://www.fda.gov/%20Safety/Recalls/EnforcementReports/default.htm) for download information.
--
- url: /data/spl/
- title: SPL
- description:
- - Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.
- - See the [SPL web site](http://www.fda.gov/forindustry/datastandards/structuredproductlabeling/) for download information.
-
diff --git a/pages/data/_meta.yaml b/pages/data/_meta.yaml
deleted file mode 100644
index 50bd4b6f..00000000
--- a/pages/data/_meta.yaml
+++ /dev/null
@@ -1,7 +0,0 @@
-documentTitle: openFDA › Datasets
-title: Datasets
-description:
-datasets:
-label:
-path: /data/
-start:
diff --git a/pages/data/_template.jsx b/pages/data/_template.jsx
deleted file mode 100644
index b9e477f8..00000000
--- a/pages/data/_template.jsx
+++ /dev/null
@@ -1,2 +0,0 @@
-import React from 'react'
-export default (props) => props.children
diff --git a/pages/data/caers/_meta.yaml b/pages/data/caers/_meta.yaml
deleted file mode 100644
index 312e3a94..00000000
--- a/pages/data/caers/_meta.yaml
+++ /dev/null
@@ -1,25 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › CAERS'
-crumbs:
- - openFDA
- - Datasets
- - CAERS
-title: 'Center for Food Safety and Applied Nutrition Adverse Event Reporting System'
-description: 'The Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) is a database that contains information on food, dietary supplement, and cosmetic product adverse events submitted to FDA.'
-source:
- name: 'CAERS'
- nameLong: 'Center for Food Safety and Applied Nutrition Adverse Event Reporting System'
- link: 'http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/ContactCFSAN/'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start: 'Q1 2014'
- current:
- delay:
- frequency:
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - "The Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) is a database that contains information on food, dietary supplement, and cosmetic product adverse events submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for foods, dietary supplements, and cosmetics."
diff --git a/pages/data/caers/index.jsx b/pages/data/caers/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/caers/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/device-recall/_meta.yaml b/pages/data/device-recall/_meta.yaml
deleted file mode 100644
index df6c70b5..00000000
--- a/pages/data/device-recall/_meta.yaml
+++ /dev/null
@@ -1,28 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › Device Recalls'
-crumbs:
- - openFDA
- - Datasets
- - Device Recalls
-title: 'Device Recalls'
-description: 'A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.'
-source:
- name: 'Device Recalls'
- nameLong: 'Device Recalls'
- link: 'http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm'
- linkDownload: 'http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start:
- current:
- delay:
- frequency: 'Monthly'
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - "A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health."
- - "In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it does two things: Recalls the device (through correction or removal), and notifies FDA."
- - "Legally, FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, FDA has rarely needed to require a medical device recall."
\ No newline at end of file
diff --git a/pages/data/device-recall/index.jsx b/pages/data/device-recall/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/device-recall/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/faers/_meta.yaml b/pages/data/faers/_meta.yaml
deleted file mode 100644
index 8c41cacc..00000000
--- a/pages/data/faers/_meta.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › FAERS'
-crumbs:
- - openFDA
- - Datasets
- - FAERS
-title: 'FDA Adverse Event Reporting System'
-description: 'The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.'
-source:
- name: 'FAERS'
- nameLong: 'FDA Adverse Event Reporting System'
- link: 'http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm'
- linkDownload: 'http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start: 'Q1 2014'
- current:
- delay: '3 months'
- frequency: 'Quarterly'
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - "The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology."
\ No newline at end of file
diff --git a/pages/data/faers/index.jsx b/pages/data/faers/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/faers/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/index.jsx b/pages/data/index.jsx
deleted file mode 100644
index 1a9cbc83..00000000
--- a/pages/data/index.jsx
+++ /dev/null
@@ -1,12 +0,0 @@
-import React from 'react'
-import Noun from '../../components/Noun'
-
-import content from './_content.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/maude/_meta.yaml b/pages/data/maude/_meta.yaml
deleted file mode 100644
index 4e9c2e8c..00000000
--- a/pages/data/maude/_meta.yaml
+++ /dev/null
@@ -1,38 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › MAUDE'
-crumbs:
- - openFDA
- - Datasets
- - MAUDE
-title: 'Manufacturer and User Facility Device Experience'
-description: 'Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.'
-source:
- name: 'RES'
- nameLong: 'Manufacturer and User Facility Device Experience'
- link: 'http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm'
- linkDownload: 'http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start: '2009'
- current:
- delay:
- frequency: 'Weekly'
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - 'Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters[^1] (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.'
- - 'Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.'
- - 'Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA.'
- - 'MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.'
- - 'Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated.'
- - 'MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions.'
- - 'Variations in trade, product, and company names affect search results. Searches only retrieve records that contain the search term(s) provided by the requester.'
- - 'Submission of a medical device report and the FDA’s release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.'
- - 'Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by "(b)(4)". If a report contains personnel or medical files information, that text is replaced by "(b)(6)". The designations "(b)(4)" and "(b)(6)" refer to the exemptions in the FOIA. For example, "(b)(4)" may be found in place of the product’s composition and "(b)(6)" may be found in place of a patient’s age.'
- - 'MAUDE is updated monthly and the search page reflects the date of the most recent update. The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed.'
- - '### About mandatory reporters'
- - 'Manufacturers and importers must submit reports when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Manufacturers must send reports of such deaths, serious injuries, and malfunctions to the FDA. Importers must send reports of deaths and serious injuries to the FDA and the manufacturer, and reports of malfunctions to the manufacturer.'
- - 'Device user facilities include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Device user facilities must submit reports when they become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury of a patient in their facility. Death reports must be sent to the FDA and the manufacturer, if known. Serious injury reports must be sent to the manufacturer or to the FDA, if the manufacturer is not known.'
\ No newline at end of file
diff --git a/pages/data/maude/index.jsx b/pages/data/maude/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/maude/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/pma/_meta.yaml b/pages/data/pma/_meta.yaml
deleted file mode 100644
index e8d2c211..00000000
--- a/pages/data/pma/_meta.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › PMA'
-crumbs:
- - openFDA
- - Datasets
- - PMA
-title: 'Premarket Approval'
-description: 'A PMA is an application submitted to FDA to request approval to market a medical device.'
-source:
- name: 'PMA'
- nameLong: 'Premarket Approval'
- link: 'http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm'
- linkDownload: 'http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start: '1976'
- current: 'Current'
- delay:
- frequency: 'Monthly'
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - "Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses."
\ No newline at end of file
diff --git a/pages/data/pma/index.jsx b/pages/data/pma/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/pma/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/product-classification/_meta.yaml b/pages/data/product-classification/_meta.yaml
deleted file mode 100644
index 5f093c1e..00000000
--- a/pages/data/product-classification/_meta.yaml
+++ /dev/null
@@ -1,26 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › Product Classification Database'
-crumbs:
- - openFDA
- - Datasets
- - Product Classification Database
-title: 'Product Classification Database'
-description: 'The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains device names and their associated product codes.'
-source:
- name: 'Product Classification Database'
- nameLong: 'FDA Product Classification Database'
- link: 'http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051637.htm'
- linkDownload: 'http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051668.htm'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start: '1976'
- current: 'Current'
- delay:
- frequency: 'Monthly'
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - "The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892."
\ No newline at end of file
diff --git a/pages/data/product-classification/index.jsx b/pages/data/product-classification/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/product-classification/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/registrationlisting/_meta.yaml b/pages/data/registrationlisting/_meta.yaml
deleted file mode 100644
index 84946cc5..00000000
--- a/pages/data/registrationlisting/_meta.yaml
+++ /dev/null
@@ -1,28 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › Registration & Listing'
-crumbs:
- - openFDA
- - Datasets
- - Registration and Listing
-title: 'Registration and Listing'
-description: 'Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments.'
-source:
- name: 'R&L'
- nameLong: 'Registration and Listing'
- link: 'http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/'
- linkDownload: 'http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start:
- current: 'Current'
- delay:
- frequency: 'Monthly'
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - "Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies."
- - "Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807)."
- - "Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE)."
\ No newline at end of file
diff --git a/pages/data/registrationlisting/index.jsx b/pages/data/registrationlisting/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/registrationlisting/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/res/_meta.yaml b/pages/data/res/_meta.yaml
deleted file mode 100644
index 96332b9a..00000000
--- a/pages/data/res/_meta.yaml
+++ /dev/null
@@ -1,28 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › RES'
-crumbs:
- - openFDA
- - Datasets
- - RES
-title: 'FDA Recall Enterprise System'
-description: 'Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.'
-source:
- name: 'RES'
- nameLong: 'FDA Recall Enterprise System'
- link: 'http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm177308.htm'
- linkDownload: 'http://www.fda.gov/%20Safety/Recalls/EnforcementReports/default.htm'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start: '2004'
- current:
- delay:
- frequency: 'Weekly'
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - "The Recall Enterprise System (RES) is an electronic data system used by FDA recall personnel to submit, update, classify, and terminate recalls."
- - "Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA). Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or civil actions, especially when the product has been widely distributed."
- - "Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA."
\ No newline at end of file
diff --git a/pages/data/res/index.jsx b/pages/data/res/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/res/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/data/spl/_meta.yaml b/pages/data/spl/_meta.yaml
deleted file mode 100644
index f5e093ae..00000000
--- a/pages/data/spl/_meta.yaml
+++ /dev/null
@@ -1,27 +0,0 @@
-type: dataset
-documentTitle: 'openFDA › Datasets › SPL'
-crumbs:
- - openFDA
- - Datasets
- - SPL
-title: 'Structured Product Labeling'
-description: 'Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.'
-source:
- name: 'SPL'
- nameLong: 'Structured Product Labeling'
- link: 'http://www.fda.gov/forindustry/datastandards/structuredproductlabeling/default.htm'
- linkDownload: 'http://www.fda.gov/forindustry/datastandards/structuredproductlabeling/'
-license:
- name: 'Public Domain and CC0'
- link: 'http://creativecommons.org/publicdomain/zero/1.0/'
-time:
- start: '2009'
- current:
- delay:
- frequency: 'Weekly'
-provider:
- name: 'FDA'
- link: 'http://www.fda.gov/'
-additionalContent:
- - "Drug manufacturers and distributors submit documentation about their products to FDA. Labeling contains a summary of the essential scientific information needed for the safe and effective use of the drug. Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information."
- - "The openFDA drug product labeling API returns data from these submissions for both prescription and over-the-counter (OTC) drugs. The labeling is broken into sections, such as indications for use (prescription drugs) or purpose (OTC drugs), adverse reactions, and so forth. There is considerable variation between drug products, since the information required for safe and effective use varies with the unique characteristics of each drug product."
\ No newline at end of file
diff --git a/pages/data/spl/index.jsx b/pages/data/spl/index.jsx
deleted file mode 100644
index 6db3d63c..00000000
--- a/pages/data/spl/index.jsx
+++ /dev/null
@@ -1,11 +0,0 @@
-import React from 'react'
-
-import Dataset from '../../../components/Dataset'
-
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/favicon.ico b/pages/favicon.ico
deleted file mode 100644
index 85a4d9fa..00000000
Binary files a/pages/favicon.ico and /dev/null differ
diff --git a/pages/getting_started/api_basics/_content.yaml b/pages/getting_started/api_basics/_content.yaml
deleted file mode 100644
index 7fb7508d..00000000
--- a/pages/getting_started/api_basics/_content.yaml
+++ /dev/null
@@ -1,66 +0,0 @@
-- '## About the openFDA API'
-- 'OpenFDA is an [Elasticsearch-based](http://www.elasticsearch.org/) [API](http://apievangelist.com/index.html) that serves public [FDA](http://www.fda.gov/) data about *nouns* like [drugs](/drug/), [devices](/device/), and [foods](/food/).'
-- 'Each of these nouns has one or more **categories,** which serve unique data—such as data about recall enforcement reports, or about adverse events. Every query to the API must go through one endpoint for one kind of data.'
-- 'Not all data in openFDA has been validated for clinical or production use. And because openFDA only serves publicly available data, it does not contain data with Personally Identifiable Information about patients or other sensitive information.'
-- 'The API returns individual results as [JSON](http://www.json.org/) by default. The JSON object has two sections:'
-- ul:
- - '`meta`: Metadata about the query, including a disclaimer, link to data license, last-updated date, and total matching records, if applicable.'
- - '`results`: An array of matching results, dependent on which endpoint was queried.'
-- '## Try the API'
-- 'The following example is a query for one report of an adverse drug event. In other words, it is a query for a single record from the **adverse event** endpoint for **drugs**.'
-- queryExplorer: oneReport
-- "## Anatomy of a response"
-- "Responses for non-`count` queries are divided into two sections, `meta` and `results`."
-- "### Meta"
-- "For non-`count` queries, the `meta` section includes a disclaimer, a link to the openFDA data license, and information about the results that follow."
-- fields:
- - meta.disclaimer
- - meta.license
- - meta.last_updated
- - meta.results.skip
- - meta.results.limit
- - meta.results.total
-- '### Results'
-- 'For non-`count` queries, the `results` section is an array of matching records.'
-- '## Query parameters'
-- 'The API supports four query parameters. The basic building block of queries is the `search` parameter. Use it to "filter" requests to the API by looking in specific fields for matches. Each endpoint has its own unique fields that can be searched.'
-- ul:
- - '`search`: What to search for, in which fields. If you don’t specify a field to search, the API will search in every field.'
- - '`count`: Count the number of unique values of a certain field, for all the records that matched the `search` parameter. By default, the API returns the 1000 most frequent values.'
- - '`limit`: Return up to this number of records that match the `search` parameter. Large numbers (above 100) could take a very long time, or crash your browser.'
- - '`skip`: Skip this number of records that match the `search` parameter, then return the matching records that follow. Use in combination with `limit` to paginate results.'
-- '## Query syntax'
-- 'Queries to the openFDA API are made up of *parameters* joined by an ampersand `&`. Each parameter is followed by an equals sign `=` and an argument.'
-- 'Searches have a special syntax: `search=field:term`. Note that there is only one equals sign `=` and there is a colon `:` between the field to search, and the term to search for.'
-- 'Here are a few syntax patterns that may help if you’re new to this API.'
-- ul:
- - '`search=field:term`: Search within a specific `field` for a `term`.'
- - '`search=field:term+AND+field:term`: Search for records that match **both** terms.'
- - '`search=field:term+field:term`: Search for records that match **either** of two terms.'
- - '`search=field:term&count=another_field`: Search for matching records. Then within that set of records, count the number of times that the unique values of a field appear. Instead of looking at individual records, you can use the `count` parameter to count how often certain terms (like drug names or patient reactions) appear in the matching set of records.'
-- 'Here are some example queries that demonstrate how these searches and the `count` parameter work, all using the drug adverse events endpoint.'
-- queryExplorer: 'searchSingleTerm'
-- queryExplorer: 'searchAll'
-- queryExplorer: 'searchAny'
-- queryExplorer: 'count'
-- '### Spaces'
-- 'Queries use the plus sign `+` in place of the space character. Wherever you would use a space character, use a plus sign instead.'
-- '### Phrase matches'
-- 'For phrase matches, use double quotation marks `" "` around the words. For example, `"multiple+myeloma"`.'
-- '### Grouping'
-- 'To group several terms together, use parentheses `(` `)`. For example, `(patient.drug.medicinalproduct:cetirizine+loratadine+diphenhydramine)`. Terms separated by plus signs `+` are treated as in a boolean OR.'
-- 'To join terms as in a boolean AND, use the term `+AND+`. For example, `(patient.drug.medicinalproduct:cetirizine+loratadine+diphenhydramine)+AND+serious:2` requires that *any* of the drug names match *and* that the field `serious` also match.'
-- '## Dates and ranges'
-- 'The openFDA API supports searching by *range* in date, numeric, or string fields.'
-- ul:
- - 'Specify an *inclusive* range by using square brackets `[min+TO+max]`. These include the values in the range. For example, `[1+TO+5]` will match **1** through **5**.'
- - 'Dates are simple to search by via range. For instance, `[2004-01-01+TO+2005-01-01]` will search for records between Jan 1, 2004 and Jan 1, 2005.'
-- '## Missing (or not missing) values'
-- ul:
- - '`_missing_`: `search` modifier that matches when a field has no value (is empty).'
- - '`_exists_`: `search` modifier that matches when a field has a value (is not empty).'
-- queryExplorer: 'missing'
-- queryExplorer: 'exists'
-- '## Timeseries'
-- 'The API supports `count` on date fields, which produces a timeseries at the granularity of **day**. The API returns a complete timeseries.'
-- queryExplorer: 'timeseries'
diff --git a/pages/getting_started/api_basics/_examples.json b/pages/getting_started/api_basics/_examples.json
deleted file mode 100644
index cdc6a5a4..00000000
--- a/pages/getting_started/api_basics/_examples.json
+++ /dev/null
@@ -1,17 +0,0 @@
-{
- "anatomy": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-10-29",
- "results": {
- "skip": 0,
- "limit": 1,
- "total": 1355
- }
- },
- "results": [
- {}
- ]
- }
-}
\ No newline at end of file
diff --git a/pages/getting_started/api_basics/_explorers.yaml b/pages/getting_started/api_basics/_explorers.yaml
deleted file mode 100644
index 02adf1d2..00000000
--- a/pages/getting_started/api_basics/_explorers.yaml
+++ /dev/null
@@ -1,57 +0,0 @@
-oneReport:
- title: One drug adverse event report
- description:
- - 'This query searches in the `drug/event` endpoint for a single record, and returns it. The record contains all kinds of information about the adverse event report, including the drugs that the patient was taking, the reactions that the patient experienced, and a good deal of other context.'
- - 'Each endpoint has its own unique fields, particular to the kind of data that it serves.'
- query: 'https://api.fda.gov/drug/event.json?limit=1'
-searchSingleTerm:
- title: Matching a single search term
- description:
- - 'This query looks in the `drug/event` endpoint for a record where one of the reported patient reactions was fatigue.'
- params:
- - 'Search for records where the field `patient.reaction.reactionmeddrapt` (patient reaction) contains **fatigue**'
- query: 'https://api.fda.gov/drug/event.json?search=patient.reaction.reactionmeddrapt:"fatigue"&limit=1'
-searchAll:
- title: Matching all search terms
- description:
- - 'This query looks in the `drug/event` endpoint for a record where **both** fatigue was a reported patient reaction **and** the country in which the event happened was Canada. The key here is the `+AND+` that joins the two search terms.'
- params:
- - 'Search for records where the field `patient.reaction.reactionmeddrapt` (patient reaction) contains **fatigue** and `occurcountry` (country where the event happened) was **ca** (the country code for Canada)'
- query: 'https://api.fda.gov/drug/event.json?search=patient.reaction.reactionmeddrapt:"fatigue"+AND+occurcountry:"ca"&limit=1'
-searchAny:
- title: Matching any search terms
- description:
- - 'This query looks in the `drug/event` endpoint for a record where **either** fatigue was a reported patient reaction **or** the country in which the event happened was Canada.'
- params:
- - 'Search for records where the field `patient.reaction.reactionmeddrapt` (patient reaction) contains **fatigue** or `occurcountry` (country where the event happened) was **ca** (the country code for Canada)'
- query: 'https://api.fda.gov/drug/event.json?search=patient.reaction.reactionmeddrapt:"fatigue"+occurcountry:"ca"&limit=1'
-count:
- title: Counting records where certain terms occur
- description:
- - 'This query looks in the `drug/event` endpoint for all records. It then returns a count of the top patient reactions. For each reaction, the number of records that matched is summed, providing a useful summary.'
- params:
- - 'Search for all records'
- - 'Count the number of records matching the terms in `patient.reaction.reactionmeddrapt.exact`. The `.exact` suffix here tells the API to count whole phrases (e.g. **injection site reaction**) instead of individual words (e.g. **injection**, **site**, and **reaction** separately)'
- query: 'https://api.fda.gov/drug/event.json?count=patient.reaction.reactionmeddrapt.exact'
-missing:
- title: Data is missing from a field
- description:
- - 'This query looks in the `drug/event` endpoint for records that are missing a company number, meaning that the report was submitted directly by a member of the public and not through a drug manufacturer.'
- params:
- - 'Search for records where the field `companynumb` is missing or empty'
- query: 'https://api.fda.gov/drug/event.json?search=_missing_:companynumb&limit=1'
-exists:
- title: 'Data in a field is present, regardless of the value'
- description:
- - 'This query looks in the `drug/event` endpoint for records that have a company number, meaning that the report was submitted through a drug manufacturer.'
- params:
- - 'Search for records where the field `companynumb` has data in it'
- query: 'https://api.fda.gov/drug/event.json?search=_exists_:companynumb&limit=1'
-timeseries:
- title: 'Counting by date, returning a timeseries'
- description:
- - 'This query looks in the `drug/event` endpoint for all records. It then returns a count of records per day, according to a certain date field (the receipt date of the adverse event report).'
- params:
- - 'Search for all records'
- - 'Count the number of records per day, according to the field `receiptdate`'
- query: 'https://api.fda.gov/drug/event.json?count=receiptdate'
\ No newline at end of file
diff --git a/pages/getting_started/api_basics/_fields.yaml b/pages/getting_started/api_basics/_fields.yaml
deleted file mode 100644
index d5a837b7..00000000
--- a/pages/getting_started/api_basics/_fields.yaml
+++ /dev/null
@@ -1,267 +0,0 @@
-type: object
-properties:
- meta:
- format:
- type: object
- description: 'This section contains a disclaimer and license information. The field `last_updated` indicates when the data files were exported.'
- possible_values:
- properties:
- type: object
- disclaimer:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Important details notes about openFDA data and limitations of the dataset."
- possible_values:
- license:
- format:
- is_exact: false
- type: string
- pattern:
- description: "Link to a web page with license terms that govern data within openFDA."
- possible_values:
- last_updated:
- format: date
- is_exact: false
- type: string
- pattern:
- description: "The last date when this openFDA endpoint was updated. Note that this does not correspond to the most recent record for the endpoint or dataset. Rather, it is the last time the openFDA API was itself updated."
- possible_values:
- results:
- type: object
- properties:
- skip:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Offset (page) of results, defined by the `skip` [query parameter](/api_basics/)."
- possible_values:
- limit:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Number of records in this return, defined by the `limit` [query parameter](/api/). If there is no `limit` parameter, the API returns one result."
- possible_values:
- total:
- format: int64
- is_exact: false
- type: number
- pattern:
- description: "Total number of records matching the search criteria."
- possible_values:
- application_number:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[BLA|ANDA|NDA]{3,4}[0-9]{6}$
- description: "This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null."
- possible_values:
- brand_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Brand or trade name of the drug product."
- possible_values:
- dosage_form:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Available dosage forms for the drug product."
- possible_values:
- type: reference
- value:
- name: "Doage forms"
- link: "http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm"
- generic_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Generic name(s) of the drug product."
- possible_values:
- manufacturer_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC."
- possible_values:
- nui:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[N][0-9]{10}$
- description: "Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT)."
- possible_values:
- type: reference
- value:
- name: "NDF-RT"
- link: "https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NDFRT/"
- package_ndc:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{5,4}-[0-9]{4,3}-[0-9]{1,2}$
- description: "This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug."
- possible_values:
- pharm_class_cs:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]."
- possible_values:
- pharm_class_epc:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`."
- possible_values:
- pharm_class_pe:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`."
- possible_values:
- pharm_class_moa:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`."
- possible_values:
- product_ndc:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{5,4}-[0-9]{4,3}$
- description: "The labeler manufacturer code and product code segments of the NDC number, separated by a hyphen."
- possible_values:
- product_type:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description:
- possible_values:
- type: reference
- value:
- name: "Type of drug product"
- link: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162063.htm
- route:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The route of administation of the drug product."
- possible_values:
- type: reference
- value:
- name: "Route of administration"
- link: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162034.htm
- rxcui:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[0-9]{6}$
- description: "The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms."
- possible_values:
- type: reference
- value:
- name: "RxNorm and RxCUI documentation"
- link: "https://www.nlm.nih.gov/research/umls/rxnorm/docs/2012/rxnorm_doco_full_2012-3.html"
- rxstring:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "RxNorm String, a normalized drug name that specifies a drug's ingredients, strength and dose form (also the brand name and/or package quantity, if applicable)."
- possible_values:
- rxtty:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "RxNorm Term Types, which are used to indicate generic and branded drug names at different levels of specificity."
- possible_values:
- spl_id:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$
- description: "Unique identifier for a particular version of a Structured Product Label for a product. Also referred to as the document ID."
- possible_values:
- spl_set_id:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[a-fA-F0-9]{8}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{4}-[a-fA-F0-9]{12}$
- description: "Unique identifier for the Structured Product Label for a product, which is stable across versions of the label. Also referred to as the set ID."
- possible_values:
- substance_name:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern:
- description: "The list of active ingredients of a drug product."
- possible_values:
- unii:
- type: array
- items:
- format:
- is_exact: true
- type: string
- pattern: ^[A-Z0-9]{10}$
- description: "Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information."
- possible_values:
- type: reference
- value:
- name: "Unique Ingredient Identifiers"
- link: "http://fdasis.nlm.nih.gov/srs/srs.jsp"
diff --git a/pages/getting_started/api_basics/_meta.yaml b/pages/getting_started/api_basics/_meta.yaml
deleted file mode 100644
index 09c37eb0..00000000
--- a/pages/getting_started/api_basics/_meta.yaml
+++ /dev/null
@@ -1,6 +0,0 @@
-documentTitle: openFDA › API basics
-crumbs:
- - API basics
-label: Getting Started
-title: API basics
-description: "OpenFDA is a powerful ElasticSearch-based API that may be different from other APIs you’ve used. Here you can learn about the query syntax, including your API key, and other tips for searching any of the openFDA categories."
diff --git a/pages/getting_started/api_basics/_template.jsx b/pages/getting_started/api_basics/_template.jsx
deleted file mode 100644
index b9e477f8..00000000
--- a/pages/getting_started/api_basics/_template.jsx
+++ /dev/null
@@ -1,2 +0,0 @@
-import React from 'react'
-export default (props) => props.children
diff --git a/pages/getting_started/api_basics/index.jsx b/pages/getting_started/api_basics/index.jsx
deleted file mode 100644
index 4e6c65d9..00000000
--- a/pages/getting_started/api_basics/index.jsx
+++ /dev/null
@@ -1,19 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../components/ContentWrapper'
-import content from './_content.yaml'
-import examples from './_examples.json'
-import explorers from './_explorers.yaml'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/getting_started/api_basics/reference/_content.yaml b/pages/getting_started/api_basics/reference/_content.yaml
deleted file mode 100644
index 15ab6360..00000000
--- a/pages/getting_started/api_basics/reference/_content.yaml
+++ /dev/null
@@ -1,86 +0,0 @@
-- '## Downloads'
-- 'OpenFDA is designed primarily for real-time queries. However, some applications may require all the data served by an endpoint, or exceed the [query limits](#authentication) or result limit (5000 records per query) in place to promote equitable access and manage load on the system.'
-- 'Because [openFDA is open source and its source code is available on GitHub](http://github.com/FDA/openfda/), you can create your own instance of openFDA without these limits and run it on your own server. You can also download the data for any openFDA endpoint, in exactly the same JSON format that query results follow, and build your own custom application that uses these JSON files. Because the format is exactly the same as API query results, you can reuse existing code that you’ve written for applications that process openFDA data. There are two things you should know about these downloads.'
-- ul:
- - '**Downloads are broken into parts.** Some categories have millions of records. For those categories, the data are broken up into many small parts. So while some categories have all their data available in a single file, others have dozens of files. Each file is a zipped JSON file.'
- - '**To keep your downloaded data up to date, you need to re-download the data every time it is updated.** Every time an endpoint is updated (which happens on a regular basis), it is possible that every record has changed, due to corrections or enhancements. That means that you cannot simply download "new" files to keep your downloaded version up to date. You need to download all available data files for the endpoint of interest.'
-- '### How to download data'
-- 'There are three ways to download data from openFDA.'
-- ul:
- - '**Download manually.** All downloadable files are available on [this page](https://open.fda.gov/downloads/). Additionally, there’s a downloads section on each endpoint’s openFDA page—for example, [drug adverse event downloads](https://open.fda.gov/drug/event/#downloads). There you can download a sampling of the data, or all of it, one file at a time.'
- - '**Write code to download the data automatically.** A json containing links to all downloadable files is available at [here](https://api_basics.fda.gov/download.json). The data files are hosted at [http://download.open.fda.gov/](http://download.open.fda.gov/).'
- - '**Synchronize with the openFDA S3 bucket.** Both current and old (archived) data files are available at **s3://download.open.api_basics.gov**, in subdirectories by date (e.g. **s3://download.open.fda.gov/2015-12-19/**). This is the only place that old data files are hosted.'
-- "## Download API fields"
-- example: downloadQuery
-- fields:
- - meta
- - results
-- "### Endpoint"
-- 'The following fields are present for each **endpoint**—e.g. `results.device.event`.'
-- fields:
- - total_records
- - export_date
- - partitions
-- "### Partitions"
-- 'The following fields are present for each object in the `partitions` list. Remember that each object represents a single file available for download.'
-- fields:
- - size_mb
- - records
- - file
-- '## Authentication'
-- 'An API key is required to make calls to the openFDA API. The key is free of charge. Your use of the API may be subject to certain limitations on access, calls, or use. These limitations are designed to manage load on the system, promote equitable access, and prevent abuse. Here are openFDA’s standard limits:'
-- ul:
- - '**With no API key:** 40 requests per minute, per IP address. 1000 requests per day, per IP address.'
- - '**With an API key:** 240 requests per minute, per key. 120000 requests per day, per key.'
-- 'If you anticipate usage above the limits provided by an API key, please [contact us](mailto:open@fda.hhs.gov). We’ll work with you to figure out a good solution to your requirements. Signing up for an API key means you agree to our [terms of service.](/terms/)'
-- '### Using your API key'
-- 'Your API key should be passed to the API as the value of the `api_key` parameter. Include it before other parameters, such as the `search` parameter. For example:'
-- '`https://api_basics.fda.gov/drug/event.json?api_key=yourAPIKeyHere&search=...`'
-- "getting-started"
-- '## HTTPS requests only'
-- 'OpenFDA requires you to use `https://api_basics.fda.gov` for all queries to ensure secure communication.'
-- '## OpenFDA fields'
-- 'Different datasets use different drug identifiers—brand name, generic name, NDA, NDC, etc. It can be difficult to find the same drug in different datasets. And some identifiers, like pharmacologic class, are useful search filters but not available in all datasets.'
-- 'OpenFDA features harmonization on drug identifiers, to make it easier to both search for and understand the drug products returned by API queries. These additional fields are attached to records in all categories, if applicable.'
-- 'When you query an endpoint, you can search by:'
-- ul:
- - 'Fields native to records served by that endpoint.'
- - 'Harmonized `openfda` fields, if they exist.'
-- 'OpenFDA does not rewrite original records. These additional fields are annotations, in special `openfda` dictionary of values.'
-- disclaimer:
- - '### Limits of openFDA harmonization'
- - 'Not all records have harmonized fields. Because the harmonization process requires an exact match, some drug products cannot be harmonized in this fashion—for instance, if the drug name is misspelled. Some drug products will have openfda sections, while others will never, if there was no match during the harmonization process. Conversely, searching in these fields will only return a subset of records from a given endpoint.'
-- 'The documentation below describes fields that you may find in an `openfda` section of an API result. They are organized by the dataset from which they originate.'
-- '### NDC'
-- 'NDC stands for [National Drug Code.](http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm) The Drug Listing Act of 1972 requires registered drug establishments to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)).'
-- 'Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs.'
-- 'Several NDC dataset fields are used to annotate records in openFDA.'
-- fields:
- - application_number
- - brand_name
- - dosage_form
- - generic_name
- - manufacturer_name
- - product_ndc
- - product_type
- - route
- - substance_name
-- '### SPL'
-- 'SPL stands for the [Structured Product Labeling](http://www.fda.gov/forindustry/datastandards/structuredproductlabeling/default.htm) standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. Drug products have associated labels that confirm to the SPL format.'
-- 'Several SPL dataset fields are used to annotate records in openFDA.'
-- fields:
- - spl_id
- - spl_set_id
- - pharm_class_moa
- - pharm_class_cs
- - pharm_class_pe
- - pharm_class_epc
- - upc
-- '### UNII'
-- 'UNII stands for [Unique Ingredient Identifier.](http://www.fda.gov/forindustry/datastandards/substanceregistrationsystem-uniqueingredientidentifierunii/default.htm) The overall purpose of the joint FDA/USP Substance Registration System (SRS) is to support health information technology initiatives by generating unique ingredient identifiers (UNIIs) for substances in drugs, biologics, foods, and devices. The UNII is a non- proprietary, free, unique, unambiguous, non semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.'
-- fields:
- - unii
-- '### RxNorm'
-- '[RxNorm](http://www.nlm.nih.gov/research/umls/rxnorm/overview.html) is a normalized naming system for generic and branded drugs; and a tool for supporting semantic interoperation between drug terminologies and pharmacy knowledge base systems. The [National Library of Medicine](http://www.nlm.nih.gov/) (NLM) produces RxNorm.'
-- fields:
- - rxcui
diff --git a/pages/getting_started/api_basics/reference/_examples.json b/pages/getting_started/api_basics/reference/_examples.json
deleted file mode 100644
index 7d062cb1..00000000
--- a/pages/getting_started/api_basics/reference/_examples.json
+++ /dev/null
@@ -1,34 +0,0 @@
-{
- "downloadQuery": {
- "meta": {
- "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.",
- "license": "http://open.fda.gov/license",
- "last_updated": "2015-12-19"
- },
- "results": {
- "device": {
- "event": {
- "total_records": 33128,
- "export_date": "2015-12-19",
- "partitions": [
- {
- "size_mb": "0.56",
- "records": 795,
- "display_name": "2012 q2 (all)",
- "file": "http://download.open.fda.gov/device/event/2012q2/device-event-0001-of-0001.json.zip"
- },
- {
- "size_mb": "0.58",
- "records": 825,
- "display_name": "2012 q3 (all)",
- "file": "http://download.open.fda.gov/device/event/2012q3/device-event-0001-of-0001.json.zip"
- },
- {
- "…": "…"
- }
- ]
- }
- }
- }
- }
-}
\ No newline at end of file
diff --git a/pages/getting_started/api_basics/reference/_fields.yaml b/pages/getting_started/api_basics/reference/_fields.yaml
deleted file mode 100644
index 9569cd91..00000000
--- a/pages/getting_started/api_basics/reference/_fields.yaml
+++ /dev/null
@@ -1,132 +0,0 @@
-type: object
-properties:
- meta:
- format:
- type: string
- description: "This section contains a disclaimer and license information. The field `last_updated` indicates when the data files were exported."
- possible_values:
- results:
- format:
- type: string
- description: "This section has an object for each of the openFDA *nouns*, and each of those has a child object for each endpoint. For example, for the `device/event` endpoint, there is a `results.device.event` object."
- possible_values:
- total_records:
- format: integer
- type: number
- description: "The total number of records in the endpoint."
- possible_values:
- export_date:
- format: integer
- type: number
- description: "The date when the data files for this endpoint were exported."
- possible_values:
- partitions:
- format:
- type: array of objects
- description: "The list of data files available for this endpoint. Each object in this list represents a single data file. Some categories have just one item in this list, but others have dozens of items."
- possible_values:
- size_mb:
- format:
- type: string
- description: "The size of the file, in megabytes (MB)."
- possible_values:
- records:
- format:
- type: integer
- description: "The number of records in this file."
- possible_values:
- file:
- format:
- type: integer
- description: "A URL at which the file can be accessed."
- possible_values:
- application_number:
- format:
- type: array of strings
- description: "This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null."
- possible_values:
- brand_name:
- format:
- type: array of strings
- description: "The brand or trade name of the product."
- possible_values:
- dosage_form:
- format:
- type: array of strings
- description: "The dosage form of the drug product."
- possible_values:
- generic_name:
- format:
- type: array of strings
- description: "The dosage form of the drug product."
- possible_values:
- manufacturer_name:
- format:
- type: array of strings
- description: "Name of company corresponding to the labeler code segment of the NDC."
- possible_values:
- product_ndc:
- format:
- type: array of strings
- description: "The labeler manufacturer code and product code segments of the NDC number, separated by a hyphen."
- possible_values:
- product_type:
- format:
- type: array of strings
- description: "The route of administration of the drug product."
- possible_values:
- route:
- format:
- type: array of strings
- description: "The type of drug product."
- possible_values:
- substance_name:
- format:
- type: array of strings
- description: "The list of active ingredients of a drug product."
- possible_values:
- spl_id:
- format:
- type: array of strings
- description: A unique identifier for a particular version of a Structured Product Label for a product. Also referred to as the document ID.
- possible_values:
- spl_set_id:
- format:
- type: array of strings
- description: "A unique identifier for the Structured Product Label for a product, which is stable across versions of the label."
- possible_values:
- pharm_class_moa:
- format:
- type: array of strings
- description: "Mechanism of action. Molecular, subcellular, or cellular level functional activity of a drug product’s pharmacologic class."
- possible_values:
- pharm_class_cs:
- format:
- type: array of strings
- description: "Chemical structure. Chemical structure classification of a pharmacologic class."
- possible_values:
- pharm_class_pe:
- format:
- type: array of strings
- description: "Physiologic effect. Tissue, organ, or organ system level functional activity of a pharmacologic class."
- possible_values:
- pharm_class_epc:
- format:
- type: array of strings
- description: "Established pharmacologic class. A pharmacologic class associated with an approved indication of an active moiety that the FDA has determined to be scientifically valid and clinically meaningful."
- possible_values:
- upc:
- format:
- type: array of strings
- description: "Documentation forthcoming."
- possible_values:
- unii:
- format:
- type: array of strings
- description: "The Unique Ingredient Identifier of the drug or substance."
- possible_values:
- rxcui:
- format:
- type: array of strings
- description: "The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dosage forms."
- possible_values:
diff --git a/pages/getting_started/api_basics/reference/_meta.yaml b/pages/getting_started/api_basics/reference/_meta.yaml
deleted file mode 100644
index 2e0b4128..00000000
--- a/pages/getting_started/api_basics/reference/_meta.yaml
+++ /dev/null
@@ -1,7 +0,0 @@
-documentTitle: openFDA › API › Reference
-crumbs:
- - API
- - Reference
-label: Learn
-title: API reference
-description: "Going beyond the basics? This reference can help you understand more about the technical details of the openFDA APIs."
diff --git a/pages/getting_started/api_basics/reference/index.jsx b/pages/getting_started/api_basics/reference/index.jsx
deleted file mode 100644
index 385fba3f..00000000
--- a/pages/getting_started/api_basics/reference/index.jsx
+++ /dev/null
@@ -1,17 +0,0 @@
-import React from 'react'
-
-import ContentWrapper from '../../../../components/ContentWrapper'
-import content from './_content.yaml'
-import examples from './_examples.json'
-import fields from './_fields.yaml'
-import meta from './_meta.yaml'
-
-export default () => (
-
-)
diff --git a/pages/getting_started/research/_tools.yaml b/pages/getting_started/research/_tools.yaml
deleted file mode 100644
index 432d58d0..00000000
--- a/pages/getting_started/research/_tools.yaml
+++ /dev/null
@@ -1,90 +0,0 @@
-- url: 'http://openfda.shinyapps.io/dash/'
- noun: Drugs
- title: 'Dashboard of drug adverse event reports'
- description:
- - 'This app brings together multiple UI elements—including charts and word clouds—to explore the whole space of adverse event reports. Concomitant drugs, common indications, and the nature of event reports can all be explored for the entire dataset or for custom searches.'
-- url: 'https://openfda.shinyapps.io/RR_D/'
- noun: Drugs
- title: 'PRR Drug'
- description:
- - 'This app uses the proportional reporting ratio (PRR) to show how common given adverse reactions are for a certain drug, compared with all other drugs. It can guide inquiry into the adverse reactions more likely to be associated with a given drug.'
-- url: 'https://openfda.shinyapps.io/RR_E/'
- noun: Drugs
- title: 'PRR Event'
- description:
- - 'This app uses the proportional reporting ratio (PRR) to show which drugs are more likely to be associated with a particular adverse reaction, compared with all other drugs. It can guide inquiry into drugs most likely to be associated with a given reaction.'
-- url: 'https://openfda.shinyapps.io/dynprr/'
- noun: Drugs
- title: 'Dynamic PRR'
- description:
- - 'This app uses the proportional reporting ratio (PRR) to show how much more commonly associated a particular reaction is with a particular drug, over time, compared with other drugs.'
-- url: 'https://openfda.shinyapps.io/ChangePoint/'
- noun: Drugs
- title: 'Change point analysis for adverse event'
- description:
- - 'This app shows changes over time in the average number of reports for particular drug and adverse reaction combinations. It can guide inquiry into increased or decreased adverse event reports, of particular reactions, or of particular drugs being reported.'
-- url: 'https://openfda.shinyapps.io/reportview/'
- noun: Drugs
- title: 'Drug adverse event report browser'
- description:
- - 'This app is an interface that supports paging through adverse event reports one at a time, with report fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/labelview/'
- noun: Drugs
- title: 'Drug product labeling browser'
- description:
- - 'This app is an interface that supports paging through drug product labeling one at a time, with labeling fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/LRTest/'
- noun: Drugs
- title: 'Likelihood ratio test for drug'
- description:
- - 'This app uses a statistical method to estimate the likelihood that a particular adverse event is a signal for a particular drug, with an adjustable statistical certainty threshold, based on the observed reporting rate of that event for the drug.'
-- url: 'https://openfda.shinyapps.io/LRTest_E/'
- noun: Drugs
- title: 'Likelihood ratio test for event'
- description:
- - 'This app uses a statistical method to estimate the likelihood that a particular drug is a signal for a particular adverse event, with an adjustable statistical certainty threshold, based on the observed reporting rate of that event for the drugs.'
-- url: 'https://openfda.shinyapps.io/drugenforceview/'
- noun: Drugs
- title: 'Drug enforcement report browser'
- description:
- - 'This app is an interface that supports paging through drug recall enforcement reports one at a time, with report fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/devicereports/'
- noun: Devices
- title: 'Device adverse event report browser'
- description:
- - 'This app is an interface that supports paging through medical device adverse event reports one at a time, with report fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/deviceenforceview/'
- noun: Devices
- title: 'Device enforcement report browser'
- description:
- - 'This app is an interface that supports paging through medical device recall enforcement reports one at a time, with report fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/deviceclassview/'
- noun: Devices
- title: 'Device classification browser'
- description:
- - 'This app is an interface that supports paging through medical device classification records one at a time, with report fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/510kview/'
- noun: Devices
- title: 'Device 510(k) browser'
- description:
- - 'This app is an interface that supports paging through medical device 510(k) clearance records one at a time, with report fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/PMAview/'
- noun: Devices
- title: 'Device PMA browser'
- description:
- - 'This app is an interface that supports paging through medical device premarket authorization records one at a time, with report fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/devicereglist/'
- noun: Devices
- title: 'Device registration & listing browser'
- description:
- - 'This app is an interface that supports paging through medical device manufacturer registration and listing records one at a time, with report fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/devicerecallview/'
- noun: Devices
- title: 'Device recall browser'
- description:
- - 'This app is an interface that supports paging through medical device recall records one at a time, with report fields presented in easy to read tables.'
-- url: 'https://openfda.shinyapps.io/foodrecallview/'
- noun: Foods
- title: 'Food enforcement report browser'
- description:
- - 'This app is an interface that supports paging through food product recall enforcement reports one at a time, with report fields presented in easy to read tables.'
diff --git a/pages/getting_started/research/index.jsx b/pages/getting_started/research/index.jsx
deleted file mode 100644
index 396ba5c1..00000000
--- a/pages/getting_started/research/index.jsx
+++ /dev/null
@@ -1,36 +0,0 @@
-import React from 'react'
-
-import Hero from '../../../components/Hero/index'
-import Layout from '../../../components/Layout'
-import ResearchBox from '../../../components/ResearchBox'
-import tools from './_tools.yaml'
-
-
-export default () => (
-
-
-
-
OpenFDA Powered Research Tools
-
- {
- tools.map((tool, i) => (
-
-
-
- ))
- }
-
-
-
-)
diff --git a/pages/img/FDA_logo_black_large.png b/pages/img/FDA_logo_black_large.png
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index 18e76d79..00000000
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diff --git a/pages/img/FDA_logo_black_xsmall.png b/pages/img/FDA_logo_black_xsmall.png
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diff --git a/pages/img/FDA_logo_blue_large.png b/pages/img/FDA_logo_blue_large.png
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diff --git a/pages/img/FDA_logo_blue_small.png b/pages/img/FDA_logo_blue_small.png
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index 3b1cc5c1..00000000
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diff --git a/pages/img/FDA_logo_blue_xsmall.png b/pages/img/FDA_logo_blue_xsmall.png
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index edcae336..00000000
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diff --git a/pages/img/apple.png b/pages/img/apple.png
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diff --git a/pages/img/area-chart.svg b/pages/img/area-chart.svg
deleted file mode 100644
index addc670a..00000000
--- a/pages/img/area-chart.svg
+++ /dev/null
@@ -1 +0,0 @@
-
\ No newline at end of file
diff --git a/pages/img/arrow-down.png b/pages/img/arrow-down.png
deleted file mode 100644
index 9cdea144..00000000
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diff --git a/pages/img/arrow-down.svg b/pages/img/arrow-down.svg
deleted file mode 100644
index 79e1c6ae..00000000
--- a/pages/img/arrow-down.svg
+++ /dev/null
@@ -1 +0,0 @@
-
\ No newline at end of file
diff --git a/pages/img/authors/jeffreyshuren.jpg b/pages/img/authors/jeffreyshuren.jpg
deleted file mode 100644
index 4322414b..00000000
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diff --git a/pages/img/authors/tahakasshout.jpg b/pages/img/authors/tahakasshout.jpg
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diff --git a/pages/img/blue-code.jpg b/pages/img/blue-code.jpg
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diff --git a/pages/img/developer.png b/pages/img/developer.png
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diff --git a/pages/img/dog.png b/pages/img/dog.png
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diff --git a/pages/img/down-arrows.svg b/pages/img/down-arrows.svg
deleted file mode 100644
index 2b5b686f..00000000
--- a/pages/img/down-arrows.svg
+++ /dev/null
@@ -1 +0,0 @@
-
\ No newline at end of file
diff --git a/pages/img/gov-fda-new-white.svg b/pages/img/gov-fda-new-white.svg
deleted file mode 100644
index 97a422ce..00000000
--- a/pages/img/gov-fda-new-white.svg
+++ /dev/null
@@ -1,228 +0,0 @@
-
-
\ No newline at end of file
diff --git a/pages/img/hero-bg.jpg b/pages/img/hero-bg.jpg
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index 35aa294f..00000000
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diff --git a/pages/img/i_external.png b/pages/img/i_external.png
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diff --git a/pages/img/l_FDA.png b/pages/img/l_FDA.png
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diff --git a/pages/img/l_openFDA.png b/pages/img/l_openFDA.png
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diff --git a/pages/img/p_binders.jpg b/pages/img/p_binders.jpg
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diff --git a/pages/img/p_chemist.jpg b/pages/img/p_chemist.jpg
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diff --git a/pages/img/p_computer.jpg b/pages/img/p_computer.jpg
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diff --git a/pages/img/p_fruit.jpg b/pages/img/p_fruit.jpg
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diff --git a/pages/img/p_knee.jpg b/pages/img/p_knee.jpg
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diff --git a/pages/img/p_lab.jpg b/pages/img/p_lab.jpg
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diff --git a/pages/img/p_mainframe.jpg b/pages/img/p_mainframe.jpg
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index d521d4c1..00000000
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diff --git a/pages/img/p_queryTool.png b/pages/img/p_queryTool.png
deleted file mode 100644
index 3d0a59e5..00000000
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diff --git a/pages/img/p_raisins.jpg b/pages/img/p_raisins.jpg
deleted file mode 100644
index d4244f1b..00000000
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diff --git a/pages/img/pill-bottle.png b/pages/img/pill-bottle.png
deleted file mode 100644
index f96c3c89..00000000
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diff --git a/pages/img/plant-leaf-with-white-details.svg b/pages/img/plant-leaf-with-white-details.svg
deleted file mode 100644
index 90e4a5cd..00000000
--- a/pages/img/plant-leaf-with-white-details.svg
+++ /dev/null
@@ -1,38 +0,0 @@
-
-
-
-
diff --git a/pages/img/posts/2014-11-04-figure-01.png b/pages/img/posts/2014-11-04-figure-01.png
deleted file mode 100644
index d08197bb..00000000
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diff --git a/pages/img/stethoscope.png b/pages/img/stethoscope.png
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index 802e595c..00000000
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diff --git a/pages/img/us_flag_small.png b/pages/img/us_flag_small.png
deleted file mode 100644
index 34b927b4..00000000
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diff --git a/pages/index.jsx b/pages/index.jsx
deleted file mode 100644
index cf7a41f2..00000000
--- a/pages/index.jsx
+++ /dev/null
@@ -1,82 +0,0 @@
-/* @flow */
-
-import React from 'react'
-
-import Layout from '../components/Layout'
-import NounBox from '../components/NounBox'
-import BlogRoll from '../components/BlogRoll'
-import type tTEMPLATE from '../constants/types/template'
-
-const Link: ReactClass = require('react-router').Link
-
-type PROPS = {
- route: Object;
-};
-
-// homepage
-const INDEX = ({ route }: tTEMPLATE) => (
-
-
-
-
Open Access to FDA Data
-
-
APIs and file downloads for FDA data, including adverse events, product labeling, and enforcement reports.
-
- Learn More
-
-
-
-
-
API Endpoint Categories
-
-
-
-
-
-
-
- VIEW ALL
-
-
-
-
-
-
API Usage Statistics
- This site also offers an overview of the usage of API endpoints by the community.
-
-
- VIEW USAGE ACTIVITY
-
-
-
-
-
-
-
Download OpenFDA Data
- The endpoints' data may be downloaded in zipped JSON format.
-
-
- DOWNLOAD ENDPOINTS
-
-
-
-
-
-
-
-
Citizen Science and Crowdsourcing
-
View some examples created by the community using OpenFDA data.
-
- SHOW ME MORE
-
-
-
-
-
-)
-
-INDEX.displayName = 'Homepage'
-export default INDEX
diff --git a/pages/license/index.md b/pages/license/index.md
deleted file mode 100644
index 7d2a8980..00000000
--- a/pages/license/index.md
+++ /dev/null
@@ -1,22 +0,0 @@
----
-layout: page
-title: Data Licensing
----
-*Last modified: May 27, 2014*
-
-
-Through openFDA, you can access a wide variety of public data that the FDA collects and publishes in machine-readable formats. We want you to fully understand the rights around this data so that you can accurately use openFDA in your work.
-
-### Terms of Service
-The [terms of service](https://open.fda.gov/terms/) govern how you may access openFDA as a service. Use of the data made available via openFDA is generally unrestricted, however, the service through which we make that data available is offered subject to your acceptance of those terms and conditions as well as any relevant sections of the [FDA Website Policies](http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm).
-
-As noted in the terms of service, unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a [Creative Commons CC0 1.0 Universal](http://creativecommons.org/publicdomain/zero/1.0/legalcode) dedication. Under CC0, FDA has dedicated the work to the public domain by waiving all rights to the work worldwide under copyright law, including all related and neighboring rights, to the extent allowed by law. You can copy, modify, distribute and perform the work, even for commercial purposes, all without asking permission.
-
-### Important CC0 Considerations
-
-- In no way are the patent or trademark rights of any person affected by CC0, nor are the rights that other persons may have in the work or in how the work is used, such as publicity or privacy rights.
-- Unless expressly stated otherwise, the person who associated a work with this deed makes no warranties about the work, and disclaims liability for all uses of the work, to the fullest extent permitted by applicable law.
-- When using or citing the work, you should not imply endorsement by the author or the affirmer.
-
-### Exemptions
-In the future, if we post data that may not be covered under the terms listed above, we will specify the data (or specifc fields inside a dataset) that is not covered and the copyright status of that work here.
\ No newline at end of file
diff --git a/pages/robots.txt b/pages/robots.txt
deleted file mode 100644
index eb053628..00000000
--- a/pages/robots.txt
+++ /dev/null
@@ -1,2 +0,0 @@
-User-agent: *
-Disallow:
diff --git a/pages/static/docs/openFDA-analysis-example.pdf b/pages/static/docs/openFDA-analysis-example.pdf
deleted file mode 100644
index 7c1348e8..00000000
Binary files a/pages/static/docs/openFDA-analysis-example.pdf and /dev/null differ
diff --git a/pages/static/docs/openFDA-technologies.pdf b/pages/static/docs/openFDA-technologies.pdf
deleted file mode 100644
index fc864912..00000000
Binary files a/pages/static/docs/openFDA-technologies.pdf and /dev/null differ
diff --git a/pages/terms/index.md b/pages/terms/index.md
deleted file mode 100644
index be6d3202..00000000
--- a/pages/terms/index.md
+++ /dev/null
@@ -1,57 +0,0 @@
----
-title: 'Terms of Service'
-date: 2014-05-22 08:30:00
-layout: post
-path: '/terms'
-showInList: false
----
-
-The U.S. Food and Drug Administration (“FDA”) offers some of its public data in machine-readable format through openFDA, a service located at https://open.fda.gov. Use of the data made available via openFDA is generally unrestricted (see “Data Rights and Usage”). However, the service through which we make that data available is offered subject to your acceptance of the terms and conditions contained herein as well as any relevant sections of the FDA Website Policies.
-
-## Scope
-
-The service (“openFDA”) through which you may access FDA public data is subject to these terms. Use of openFDA constitutes acceptance to this Agreement.
-
-### Data Rights and Usage
-
-Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication. In short, FDA waives all rights to the work worldwide under copyright law, including all related and neighboring rights, to the extent allowed by law. You can copy, modify, distribute, and perform the work, even for commercial purposes, all without asking permission. FDA makes no warranties about the work, and disclaims liability for all uses of the work, to the fullest extent permitted by applicable law.
-
-Some data on openFDA may not be public domain, such as copies of copyrightable works made available to the FDA by private entities. FDA may make these works available under the fair use provision of the Copyright Act or as a result of regulatory directives. Therefore, your rights to use those works may be similarly limited. Works where CC0 do not apply will be clearly marked by a warning in the relevant documentation (for example: “This data is not in the public domain. Third party copy rights may apply.”).
-
-### Attribution
-
-While not required, when using content, data, documentation, code, and related materials from openFDA in your own work, we ask that proper credit be given. An example citation is provided below:
-
-Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)
-
-### Right to Limit
-
-Your use of openFDA may be subject to certain limitations on access, calls, or use as set forth within this Agreement or otherwise provided by FDA. These limitations are designed to manage load on the system, promote equitable access, and prevent abuse. If FDA reasonably believes that you have attempted to exceed or circumvent these limits, your ability to use openFDA may be temporarily or permanently restricted. FDA may monitor your use of openFDA to improve the service or to ensure compliance with this Agreement.
-
-### Service Termination
-
-If you wish to terminate this Agreement, you may do so by refraining from further use of openFDA. FDA reserves the right (though not the obligation) to refuse to provide openFDA to you if it is FDA’s opinion that use violates any FDA or Federal policy or law. FDA also reserves the right to stop providing openFDA at any time for any reason in its sole discretion. All provisions of this Agreement, which by their nature should survive termination, shall survive termination including warranty disclaimers and limitations of liability.
-
-### Changes
-
-FDA reserves the right, at its sole discretion, to modify or replace this Agreement, in whole or in part. Your continued use of or access to openFDA following posting of any changes to this Agreement constitutes acceptance of those modified terms. FDA may in the future, offer new services and/or features through openFDA. Such new features and/or services shall be subject to the terms and conditions of this Agreement.
-
-### Disclaimer of Warranties
-
-The openFDA platform is provided “as is” and on an “as-available” basis. While we will do our best to ensure the service is available and functional as much as possible, FDA hereby disclaim all warranties of any kind, express or implied, including without limitation the warranties of merchantability, fitness for a particular purpose, and non-infringement. FDA makes no warranty that openFDA data will be error free or that access thereto will be continuous or uninterrupted.
-
-### Limitations on Liability
-
-In no event will FDA be liable with respect to any subject matter of this Agreement under any contract, negligence, strict liability or other legal or equitable theory for: (1) any special, incidental, or consequential damages; (2) the cost of procurement of substitute products or services; or (3) for interruption of use or loss or corruption of data.
-
-### Miscellaneous
-
-This Agreement constitutes the entire Agreement between FDA and you concerning the subject matter hereof, and may only be modified by the posting of a revised version on this page by the FDA.
-
-### Disputes
-
-Any disputes arising out of this Agreement and access to or use of openFDA shall be governed by federal law.
-
-### No Waiver Rights
-
-FDA’s failure to exercise or enforce any right or provision of this Agreement shall not constitute waiver of such right or provision.
diff --git a/utils/flattenFields.jsx b/utils/flattenFields.jsx
deleted file mode 100644
index d1f10ed7..00000000
--- a/utils/flattenFields.jsx
+++ /dev/null
@@ -1,34 +0,0 @@
-/* @flow */
-
-import each from 'lodash/each'
-import isObject from 'lodash/isObject'
-
-// Completely flatten a nested object into an object with dot-notation
-// Turns the results of getFieldNamesAndChartTypes into a useful object for the infographic explorer UI
-// e.g.
-// {
-// 'report': 'bar',
-// 'date': 'line',
-// 'patient.drug.name': 'bar',
-// 'patient.drug.openfda.brand_name': 'bar',
-// 'patient.drug.openfda.number': 'bar'
-// }
-const completelyFlatten = function (
- item: Object|Array,
- result: Object = {},
- prefix: void|string): Object {
-
- if (isObject(item)) {
- each(item, function (val, key) {
- const pre: string = prefix ? `${prefix}.${key}` : key
- return completelyFlatten(val, result, pre)
- })
- }
- else {
- result[prefix] = item
- }
-
- return result
-}
-
-export default completelyFlatten
diff --git a/utils/getFieldValues.jsx b/utils/getFieldValues.jsx
deleted file mode 100644
index 08694872..00000000
--- a/utils/getFieldValues.jsx
+++ /dev/null
@@ -1,42 +0,0 @@
-/* @flow */
-
-import yamlGet from './yamlGet'
-
-// Find field values if appropriate, for substition
-// e.g. patient.drug.drugadministrationroute
-// 004 = "Dental"
-// We want to present the string "Dental"
-const getFieldValues = function (countParam: string, fields: Object): Object {
- // Donut doesn't always get fields and queryCount,
- // but still needs to render. For example, when it appears
- // under the filters and shows the proportion of queries
- // that match search criteria.
- let fieldDef: ?Object = null
-
- if (fields && countParam) {
- fieldDef = yamlGet(countParam, fields)
- }
-
- if (!fieldDef || !fieldDef.possible_values) return {}
-
- let fieldValues: Object = {}
- const possibleValues: void|Object = fieldDef.possible_values
-
- let type: string = ''
- let len: number = 0
-
- if (possibleValues) {
- len = possibleValues.value ? Object.keys(possibleValues.value).length : 0
- type = possibleValues.type ? possibleValues.type.toLowerCase() : ''
- }
-
- if (possibleValues &&
- type === 'one_of' &&
- len >= 1) {
- fieldValues = possibleValues.value
- }
-
- return fieldValues
-}
-
-export default getFieldValues
diff --git a/utils/mapFields.jsx b/utils/mapFields.jsx
deleted file mode 100644
index ac5d79d9..00000000
--- a/utils/mapFields.jsx
+++ /dev/null
@@ -1,92 +0,0 @@
-/* @flow */
-
-import each from 'lodash/each'
-
-// Traverses the endpoint field documentation and gets the field names and types
-// e.g.
-// {
-// report: 'bar',
-// date: 'line',
-// patient: {
-// drug: {
-// name: 'bar',
-// openfda: {
-// brand_name: 'bar',
-// number: 'bar'
-// }
-// }
-// }
-// }
-const getFieldNamesAndChartTypes = function (fields: Object): Object {
- const fieldMap: Object = {}
-
- each(fields, function (val, key) {
- // If this field is one that wants to be counted with .exact
- // (e.g. a product name field), it needs to be represented with
- // .exact appended to the ordinary key name
- let exactKey: ?string = null
-
- // recursion if we meet an field with type object
- if (val.type === 'object') {
- fieldMap[key] = getFieldNamesAndChartTypes(val.properties)
- return
- }
-
- // This array contains multi-field objects
- // e.g. in /drug/event patient.drug is an array of drug objects
- if (val.type === 'array' && val.items.properties) {
- fieldMap[key] = getFieldNamesAndChartTypes(val.items.properties)
- return
- }
-
- // because of recursion
- // we should be looking at an individual field at this point
- // if not array/object, checking .is_exact is enough
- // if array/object, we need to go 1 level deeper
- const isExact: boolean = val.is_exact || (val.items && val.items.is_exact)
- if (isExact) {
- exactKey = `${key}.exact`
- }
-
- // Determine what kind of chart we will want to draw based on the field content/data
- if (val.format === 'date') {
- fieldMap[key] = 'Line'
-
- if (isExact) {
- fieldMap[exactKey] = 'Line'
- }
-
- return
- }
-
- if (val.possible_values) {
- const vals: Object = val.possible_values
-
- if (vals.type !== 'one_of') return
-
- const isShort: boolean = Object.keys(vals.value).length < 10
-
- // we only want to use donut charts
- // when we can easily fit the data
- if (!isShort) return
-
- fieldMap[key] = 'Donut'
- if (isExact) {
- fieldMap[exactKey] = 'Donut'
- }
-
- return
- }
-
- // N.B. If this array contains a single field, it gets treated like an ordinary field
- // e.g. in /drug/event patient.drug.openfda.brand_name is an array of strings
- fieldMap[key] = 'Bar'
- if (isExact) {
- fieldMap[exactKey] = 'Bar'
- }
- })
-
- return fieldMap
-}
-
-export default getFieldNamesAndChartTypes
diff --git a/utils/xhr.jsx b/utils/xhr.jsx
deleted file mode 100644
index 3a15cd87..00000000
--- a/utils/xhr.jsx
+++ /dev/null
@@ -1,32 +0,0 @@
-/* @flow */
-
-/**
- * @description [takes in a query string, returns JSON]
- * [will attempt to fetch from storage first]
- * [request will be made if not in storage]
- * @param {string} [query] the url to query
- * @param {Function} [cb] [callback function to use on success]
- * @param {boolean} [cache] [by default we cache, but sometimes we don't want to]
- * @returns {Object} [regardless of how the data is got, return JSON]
- */
-
-const xhrGET = function (query: string, cb: Function) {
- // if not caching, always make a request
- // for example, api status should never be cached
- const xhr = new XMLHttpRequest()
- xhr.open('GET', query, true)
- xhr.onload = function () {
- // 404s, rate-limiting, etc
- if (xhr.status > 400) {
- console.error('bad request: ', xhr.status)
- }
-
- // callback function defined in calling file
- // ie, where the calling component will handle the res
- return cb(JSON.parse(xhr.responseText))
- }
-
- xhr.send()
-}
-export default xhrGET
-
diff --git a/utils/yamlGet.jsx b/utils/yamlGet.jsx
deleted file mode 100644
index 9fcab39f..00000000
--- a/utils/yamlGet.jsx
+++ /dev/null
@@ -1,67 +0,0 @@
-/* @flow */
-
-import get from 'lodash/get'
-
-// Find a field in a _fields.yaml
-//
-// Plain field name (used in an API query):
-// patient.drug.medicinalproduct.exact
-// In _fields.yaml:
-// patient.properties.drug.items.properties.medicinalproduct
-//
-// This requires traversing the yaml to inspect each leaf of the
-// hierarchy, finding the right verbose path at which to get
-// the original field definition.
-
-const yamlGet = function (field: string, fieldsYAML: Object): void|Object {
- // Strip out 'exact', split into array
- const pathParts: Array = field
- .split('.')
- .filter(item => item !== 'exact')
-
- const newPathParts = []
-
- pathParts.forEach(part => {
- newPathParts.push(part)
- // openfda -> openfda.route -> openfda.route.exact
- let currentPath: string = newPathParts.join('.')
- // currentPath must be the absolute path to get field
- let currentResult: void|Object = get(fieldsYAML.properties, currentPath)
-
- if (!currentResult || !currentResult.type) return
-
- const type: string = currentResult.type.toLowerCase()
-
- // If the current path takes us to an…
- // Object: push 'properties' to the path
- if (type === 'object') {
- newPathParts.push('properties')
- }
- // Array: push 'items' to the path
- else if (type === 'array') {
- newPathParts.push('items')
- currentPath = newPathParts.join('.')
-
- // Array may contain scalars, objects, or arrays…
- currentResult = get(fieldsYAML.properties, currentPath)
- if (currentResult.properties) {
- newPathParts.push('properties')
- }
- if (currentResult.items) {
- newPathParts.push('items')
- }
- }
- })
-
- const newPath: string = newPathParts.join('.')
-
- try {
- const result = get(fieldsYAML.properties, newPath)
- if (result) return result
- }
- catch (err) {
- console.error('error getting yaml: ', err)
- }
-}
-
-export default yamlGet
diff --git a/wrappers/html.jsx b/wrappers/html.jsx
deleted file mode 100644
index d0f10ef4..00000000
--- a/wrappers/html.jsx
+++ /dev/null
@@ -1,40 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import dateFormat from 'dateformat'
-
-import Hero from '../components/Hero'
-import Layout from '../components/Layout'
-import type tTEMPLATE from '../constants/types/template'
-
-const MD = ({ route }: tTEMPLATE) => {
- const post: Object = route.page.data
-
- // Some posts don’t have authors. If the post has authors,
- // join their names as a string, comma-separated.
- let postAuthors: string = ''
- if (post.authors) {
- postAuthors = post.authors.join(', ')
- }
-
- return (
-
-
-
-
-
-
- )
-}
-
-MD.displayName = 'wrappers/md'
-module.exports = MD
diff --git a/wrappers/md.jsx b/wrappers/md.jsx
deleted file mode 100644
index 2165420c..00000000
--- a/wrappers/md.jsx
+++ /dev/null
@@ -1,43 +0,0 @@
-/* @flow */
-
-import React from 'react'
-import dateFormat from 'dateformat'
-
-import Hero from '../components/Hero'
-import Layout from '../components/Layout'
-import type tTEMPLATE from '../constants/types/template'
-
-const MD = ({ route }: tTEMPLATE) => {
- const post: Object = route.page.data
-
- // Some posts don’t have authors. If the post has authors,
- // join their names as a string, comma-separated.
- let postAuthors: string = ''
- if (post.authors) {
- postAuthors = post.authors.join(', ')
- }
-
- return (
-
- to exist
- description={postAuthors ? postAuthors : ' '}
- />
-
-
-
-
- )
-}
-
-MD.displayName = 'wrappers/md'
-module.exports = MD